Major Big Pharma Moves, Pressures of Capital Markets at Intersection with Autologous Versus Allogeneic

Behind the Headlines Episode 25

Questions about Real-World Evidence and Supply Chain Security

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains

Responses to the FDA draft guidance "Considerations for Complying with 21 CFR 211.110"

Stakeholders React to FDA's Push for Quality, Integrity, and Uniformity

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

RFID chips and tags | Image Credit: © Albert Lozano-Nieto - stock.adobe.com

Schreiner MediPharm, a business unit of Germany-based 

, is previewing a novel label option with radio frequency identification (RFID) technology that the company will showcase at CPHI Frankfurt 2025, to be held from Oct. 28–30 (1). According to an Oct. 8, 2025 press release, Schreiner MediPharm says the label, which is branded “Cap-Lock,” is designed to provide optimal protection for syringes, increasing digitalization and efficiency.

How do the label and RFID functionality work?

Among other solutions Schreiner MediPharm plans to display at the conference, the Cap-Lock labels will be presented in combination with 

’s infuse cyclic olefin copolymer syringes (1). This design, according to the press release, safeguards the integrity of the prefilled syringe until final use, replacing the usual blister pack with a sustainable alternative that reduces carbon dioxide and cost.

As for the RFID functionality, an embedded chip in the label provides a digital indication of first opening—which, especially for hospitals, will allow for automated tracking of syringe integrity until a medication is administered (1). The chip also automatically detects expired drugs and can be used to monitor potential misuse or diversions.

SCHOTT’s TOPPAC infuse, the brand name for its syringe in this collaboration with Schreiner MediPharm, 

has been nominated for a CPHI Pharma Award

 in the category of packaging and machinery (2). Winners will be announced at the conference’s opening ceremony on Oct. 28.

What further implications could this have for pharma?

In early-stage formulations, maintaining container integrity is crucial. The ability to digitally detect first opening, rather than relying solely on visual cues or audits, could help in monitoring whether samples have been compromised during transport or handling. Such monitoring is especially relevant in multi-site studies, cold-chain challenging payloads, or decentralized trials. Moreover, by substituting conventional blister packaging, the approach proposed by Schreiner MediPharm offers a more compact, possibly lower-thermal-mass solution, which can potentially be advantageous in cold-chain logistics and stability studies.

Regulators are increasingly emphasizing supply chain security, serialization, and anti-tampering measures, and so a label that integrates mechanical tamper evidence plus RFID-driven digital tracking may help manufacturers meet or exceed those standards. For good manufacturing practice operations, reliably embedding electronics into labeling without compromising sterility, compatibility (e.g., extractables and leachables), or process robustness will be key.

From a manufacturing perspective, such integrated smart labels must be robust enough to survive high-speed dispensing, capping, and downstream handling. Schreiner MediPharm claims that its technology is constructed to resist mechanical stress during production, thus preserving readability without inducing additional rejects or read failures (1). If validated at scale, that reduces the risk of lines being slowed or scrapped due to label reading failures.

However, adoption will require pharma manufacturers to evaluate whether their existing fill/finish lines can accommodate label placement, RFID encoding, reading, and verification infrastructure. The ROI will rest on reductions in packaging operations (e.g., eliminating blister packs), supply chain efficiencies (reduced returns waste, better inventory control), and enhanced patient safety or liability reduction.

Schreiner MediPharm’s booth at CPHI is No. 8.0B42, in Hall 8 (1).

Cap-Lock Plus RFID: Schreiner MediPharm to Present Innovative Security Solution at CPHI Frankfurt 2025.

 Press Release. Oct. 8, 2025.
2. Mirasol, F. 

CPHI Frankfurt Reveals 2025 Pharma Awards Finalists for Bio/Pharma Development.

Articles

Schreiner MediPharm is introducing an innovative RFID-enabled label, "Cap-Lock," designed to enhance syringe protection and digitalization. This label, showcased at CPHI Frankfurt 2025, integrates with SCHOTT Pharma's syringes, offering a sustainable alternative to traditional blister packs. The RFID chip provides digital tracking of syringe integrity, detects expired drugs, and monitors misuse. This technology aligns with regulatory demands for supply chain security and anti-tampering measures. Adoption requires evaluating existing manufacturing lines for compatibility with RFID infrastructure, promising operational efficiencies and enhanced patient safety.

The new label for prefilled syringes, in conjunction with innovations from SCHOTT Pharma, enables integrated tamper-evidence and digital tracking across the supply chain.

What Schreiner MediPharm’s RFID-Embedded Label Launch at CPHI Frankfurt Means for Manufacturing

Feliza Mirasol is the science editor for 

Human head | Image Credit: © ShpilbergStudios - stock.adobe.com

, being held Oct. 6–8 in Phoenix, Ariz., panelists indicated that the rapid scientific acceleration within the cell and gene therapy (CGT) sector that is yielding transformative clinical data across new cancer (e.g., glioblastoma, ovarian) and non-cancer indications is placing immense pressure on the current manufacturing infrastructure.

Industry leaders convened during the session titled “The New Standard for CGT Manufacturing: Flexibility and Scalability” on Oct. 6 to address this bottleneck, arguing that the industry must transition to a new paradigm—labeled CGT 2.0—that delivers both flexibility and scalability simultaneously (1).

, CEO and executive director of Ori Biotech, the panel stressed that the traditional trade-off between maintaining process flexibility for early-stage development and planning for large-scale commercial viability is no longer sustainable.

"The idea is to provide flexibility and scalability at the same time, and we're going to talk about how we do that; and that really is a hallmark of what I would call CGT 2.0," Foster said at the start of the panel discussion (1).

For the biopharmaceutical industry, success in CGTs can no longer be defined solely by clinical efficacy, the panel discussion revealed. 

, chief strategy officer and head of artificial intelligence (AI) at OmniaBio, emphasized the need for a "working backward" approach, in which the end state is defined by widespread patient access and affordability. This approach means that manufacturing must be viable not just in large academic medical centers (AMCs), such as California-based City of Hope or Children’s Hospital of Philadelphia (CHOP), but deliverable in community hospital settings.

"If you ask 90% of the people in this industry what their end state is, it's a clinically effective and safe product,” Harris said during the panel. “That is one of the pillars, but that is not the only pillar."

Meanwhile, neglecting chemistry, manufacturing, and controls (CMC) early on results in a non-viable product, emphasized 

, vice-president, Cell and Gene Therapy Operations, City of Hope. Ahsan confirmed that due diligence by potential partners is increasingly focused on manufacturing viability, making CMC a "dealbreaker" even when clinical data are promising. "The clinical data, or even the animal data, will bring [partners] to the table, but, more and more, their due diligence is super focused on the CMC, and that is turning into deal breakers," she stated.

What do platform processes and modular systems bring to the table?

To enable flexibility, AMCs, such as City of Hope, are leveraging platform processes—modular units that are already vetted and can support multiple investigational new drug (IND) applications rapidly. For example, City of Hope uses a few platforms to support 18 INDs, Ahsan pointed out.

, senior vice-president, Innovation Ventures, Children’s Hospital of Philadelphia (CHOP), also highlighted the notion that future flexibility requires defining modular and interoperable systems that are compatible with various cell types, delivery systems, and payloads, including stem cell work, chimeric antigen receptor T cells (CAR-T), and personalized gene editing therapies. "Over the past 10 years, it really has been … academic medical centers that have developed these processes initially," Wilton said.

What strategies can be used to reduce end-product variability?

A major hurdle for scaling CGT manufacturing is process variability. Even highly trained human operators invariably introduce variation that batch records cannot capture, noted 

, senior director, Allogeneic and Autologous Cell Therapy Development, Johnson & Johnson Innovative Medicine, in the panel. This human factor makes automation crucial for reproducibility and rapid scalability, Snowden pointed out.

Simple automation in manual processes is considered "low hanging fruit" for improving quality and reducing costs, Snowden commented. "[One will] see an extraordinary amount of variability because of the subtleties of the execution that can never be put into a batch record or training without them turning into a novel sized document," he explained.

Furthermore, the industry suffers from a significant data gap as it often fails to analyze or share the data collected. Harris explained that OmniaBio, in addressing this data gap, utilized a simple AI platform to analyze human labor and process steps in their operations and identified 27% cost savings in labor, underscoring the immediate financial impact of leveraging basic analytics. The ultimate goal is adaptive control, in which systems use machine learning to guide real-time manufacturing decisions, Harris stated.

What is the benefit of building a collaborative CGT ecosystem?

The panelists concluded that achieving CGT 2.0 requires a profound "mentality shift" from viewing development as a research endeavor to treating it as a commercialization program. Collaboration is paramount to eliminating time-consuming tech transfers, which can currently take 12 to 24 months, the panelists discussed.

AMCs, for instance, must partner with technology providers to offer a "sandbox" environment for rapid iteration and enhancement of new manufacturing platforms, ensuring they are suitable across all patient populations. The panelists agreed that industry players must come together and prioritize what benefits the overall field, rather than individual organizations, which entails promoting data sharing and interoperability. In this way, the entire CGT sector can move toward exponential growth and widespread patient access. The elimination of bottlenecks, identified early through principles such as Kaizen (2) or the Theory of Constraints (3), and optimizing the "last mile" logistics (product delivery to the patient) are also essential to driving down the persistently high cost of goods.

1. Cell and Gene Meeting on the Mesa. The New Standard for CGT Manufacturing: Flexibility and Scalability. Presentation at Cell and Gene Meeting on the Mesa, Oct. 6, 2025. 


2. Abuzied, Y. A Practical Guide to the Kaizen Approach as a Quality Improvement Tool. 

Theory of Constraints (TOC) of Dr. Eliyahu Goldratt

The rapid advancements in cell and gene therapy (CGT) are challenging existing manufacturing infrastructures, necessitating a shift to a new paradigm, CGT 2.0, which emphasizes flexibility and scalability. Success in CGT now requires not only clinical efficacy but also widespread patient access and affordability. The focus on chemistry, manufacturing, and controls (CMC) is crucial for product viability. Automation and data analytics are key to reducing variability and costs. Collaboration across the industry is essential to overcome bottlenecks and achieve exponential growth and patient access.

At the Cell and Gene Meeting on the Mesa, a panel discussion was held on advanced therapy production and how it demands modular platforms, automation, and data governance to drastically improve patient access and affordability.

The Importance of Building in Flexibility and Commercial Viability Early in the CGT Scaling Process

Stop alcohol concept. Person refuse to drink alcohol. | Image Credit: © Pormezz - stock.adobe.com

Miami-based clinical-stage biopharmaceutical company 

 has been awarded a $1.7 million Small Business Innovation Research grant from the National Institute on Alcohol Abuse and Alcoholism, part of the United States National Institutes of Health, aimed at advancing DemeRx’s neuroplastogen drug candidate DMX-1001 (noribogaine) (1). The funding, according to an Oct. 7, 2025 press release, is designed to move DemeRx’s candidate through necessary investigational new drug-enabling studies and toward Phase II clinical trials for treatment of alcohol use disorder (AUD).

DemeRx said that its noribogaine candidate takes a novel therapeutic approach of targeting multiple central nervous system areas, with a desired result of rapid intervention that reduces not only cravings, but also the compulsion to drink alcohol (1). Because the treatment additionally promotes neuroplasticity, it works to normalize neurotransmitter signaling, lowering a risk of relapse and potentially reversing long-term effects of AUD.

A Phase Ib trial evaluating the pharmacokinetics, pharmacodynamics, and safety of multiple ascending doses of DMX-1001 has been completed, DemeRx said (1). In previous Phase I trials, it was well-tolerated and found to be safe.

According to multiple sources cited by DemeRx, AUD impacts more than 29 million people in the US and is a leading cause of preventable death (1). While fewer than 5% of the population said to be affected by AUD receives medication, approximately 60% of those who are treated relapse to a hazardous level of drinking within six months.

"Alcohol use disorder affects many American families, and current therapeutic options remain limited,” 

 PhD, CEO and founder of DemeRx, said in the company’s press release (1). “The high rates of relapse highlight the urgent need for effective treatments. This grant not only validates our therapeutic approach but also underscores the potential of DMX-1001 to offer a transformative solution for those seeking treatment."

What uses have other neuroplastogen treatments had?

In June 2025, news came that two other neuroplastogen candidates were advancing. 

, a biotechnology company with a focus on developing therapies for difficult-to-treat neurological disorders, and 

, which specializes in organ-on-a-chip technology, 

 to accelerate preclinical development of Psilera’s lead compound, PSIL-006, which integrates next-generation neuroplastogen to target frontotemporal dementia (2).

Elsewhere, the Franco-Belgian biotech venture 

 raised €11.25 million (US$13.1 million) in an oversubscribed seed round 

to advance a first-in-class neuroplastogen

 that targets the intracellular protein Elk1, aiming to restore neuroplasticity—without the drawbacks of current options like psychedelics or ketamine derivatives—to address the challenge of treatment-resistant depression (3).

DemeRx expects that the outcomes of its Phase Ib trial, which was conducted in healthy volunteers, will inform the progression of its noribogaine candidate into its Phase II study, involving patients with AUD (1).

DemeRx Awarded $1.7 Million National Institutes of Health Grant to Advance Potential First-in-Class Neuroplastogen Drug Candidate DMX-1001 for Alcohol Use Disorder (AUD).

 Press Release. Oct. 7, 2025.
2. Hesperos. 

Psilera Collaborates with Drug Development Leader Hesperos to Advance Preclinical Modeling of PSIL-006 for Frontotemporal Dementia.

 Press Release. June 9, 2025.
3. Cole, C. 

Elkedonia Raises €11.25M Seed Round to Advance Neuroplastogen Therapy for Depression.

DemeRx, a Miami-based biopharmaceutical company, received a $1.7 million grant from the National Institute on Alcohol Abuse and Alcoholism to advance its neuroplastogen drug candidate, DMX-1001 (noribogaine), for treating alcohol use disorder (AUD). Noribogaine targets multiple central nervous system areas to reduce cravings and compulsion, promoting neuroplasticity and normalizing neurotransmitter signaling. A Phase Ib trial confirmed its safety and tolerability. AUD affects over 29 million Americans, with high relapse rates. Other neuroplastogen treatments are also advancing for neurological disorders and treatment-resistant depression.

The awarded $1.7 million in funding will support the company’s preclinical and clinical progress on DMX-1001 (noribogaine), designed to reduce relapse and improve brain health in patients with alcohol use disorder.

DemeRx’s Neuroplastogen Candidate Signals New Alcohol Use Disorder Approach

 is Global Strategic Marketing Manager, Roquette.

, is Application and Innovation Technical Service Manager, Roquette.

Prescription medicine bottle and oral syringe for baby isolated on blue background | Image Credit: © nd700 - stock.adobe.com

Patient-centric drug development is essential to improve patient outcomes, experience, and engagement. By focusing on patients’ needs, experiences, and preferences, drug developers can create treatments that are optimally effective and tolerated. This leads to improved adherence to treatment regimens and better overall health outcomes when compared with not taking these factors into consideration (1). Regulatory bodies like FDA emphasize the importance of patient-focused drug development. They provide guidance on incorporating patient input into drug development and evaluation, which can facilitate smooth regulatory approval processes (2). Ensuring that patients’ needs and preferences are central to drug development acknowledges them as key stakeholders in their own healthcare. It respects their autonomy and dignity. Patient-centric approaches encourage understanding the patient population or sub-groups (through various forms of research) and using the information to inform drug development.

Certain populations, such as pediatric, geriatric, and dysphagic patients and those with chronic conditions, can struggle with taking medicine. Children often have difficulty swallowing tablets and may be sensitive to the taste of medications. Older adults often face such challenges as dysphagia (difficulty swallowing), polypharmacy (taking multiple medications), and cognitive impairments. Patients with dysphagia require medications that are easy to swallow or do not require swallowing at all. Patients with chronic conditions may often require long-term medication and benefit from fixed-dose combinations and extended-release formulations, which can improve adherence (3). These populations demonstrate the breadth of challenges facing drug product formulators, such as swallowing difficulty, poor palatability, dosing accuracy, and complicated or overwhelming medication regimes, all of which can result in poor compliance. Thus, it is important to consider patient-friendly drug delivery formats for these populations.

Patient-centric oral drug design focuses on creating medications that are easier and more pleasant for patients to take, thereby improving compliance and overall treatment outcomes. Approaches that can appeal to individuals that have difficulty swallowing include chewable tablets, fast-dissolving films or tablets, liquids, and particulate or granule sachets. Chewable tablets are designed to be chewed and swallowed, making them easier for children and adults who have difficulty swallowing tablets whole. They often come in pleasant flavors to enhance the experience. Fast-dissolving films and tablets dissolve quickly in the mouth without the need for water. They are convenient for patients who have trouble swallowing or need medication on the go. Sachets contain powdered, granulated, or particulate medication that can be mixed with water or food, offering convenient drug administration. Liquid formulations are ideal for patients who cannot swallow tablets or prefer a liquid form. They allow for flexible dosing and can be flavored to mask the taste of the medication.

The pharmaceutical liquid suspensions market is experiencing significant growth, driven by a compound annual growth rate of 6.5%, with projections to reach $5.2 billion by 2033 (4). This growth is driven by the increasing demand for patient-focused formulations for such populations as older adults. Approximately 27–29% of older patients report difficulties with swallowing, which can significantly impact their ability to take medications and lead to issues like aspiration pneumonia, malnutrition, and weight loss (5,6). Liquid suspensions offer ease of administration and flexible dosing, making them a preferred choice for older adults.

Technological advancements have played a crucial role in enhancing the stability, bioavailability, and palatability of liquid suspensions. Such innovations as nanotechnology and taste masking techniques have improved the overall patient experience (4,7). Additionally, the development of extended release formulations has reduced dosing frequency, further improving patient compliance (4). Liquid suspensions can enhance patient compliance due to easier administration and better palatability—particularly important for patients with chronic conditions requiring long-term medication (8).

For patients with dysphagia, or difficulty swallowing, thickened liquid suspensions provide a safer alternative to thin liquids, which can pose a risk of aspiration (4,7). Thickened liquids flow more slowly, allowing for better control during swallowing and reducing the risk of choking (4,7). This makes liquid suspensions a viable option for delivering medications to patients with dysphagia, ensuring treatment without compromising safety (7). While 42.4% of patients generally prefer tablet dosage forms, liquid suspensions are favored by those with swallowing difficulties, allowing for precise and flexible dosing that can improve adherence (1,9).

Three main types of oral liquid drug delivery systems exist: solutions, suspensions, and emulsions. Solutions are homogeneous mixtures in which the drug is completely dissolved in a solvent, which ensures uniform drug distribution, leading to consistent dosing and rapid absorption. Suspensions consist of finely divided drug particles dispersed in a liquid medium, useful for drugs that are insoluble in water. Proper formulation ensures that the particles remain evenly distributed and do not settle quickly. Emulsions are defined as mixtures of two immiscible liquids, typically oil and water. They are stabilized by emulsifying agents and can enhance the bioavailability of drugs that are poorly soluble in water.

Effective oral liquid drug products must have good stability, palatability, and preservation. Ensuring the physical and chemical stability of the formulation is critical. Such factors as pH, temperature, and light exposure can affect the stability of liquid formulations. Proper formulation and packaging can help to maintain stability. Techniques to improve palatability are essential, especially for pediatric and geriatric patients. Flavoring agents, sweeteners, and taste-masking technologies can be used to enhance the taste of liquid medications. Preventing microbial growth is crucial for the safety of liquid formulations; thus, the addition of preservatives ensures that the product inhibits microbial contamination throughout its shelf life.

Excipient selection in oral liquid dosage forms

Choosing appropriate excipients is a vital step for solubility, stability, and taste. Excipients, such as solvents, suspension aids, stabilizers, and flavoring agents, play a significant role in the overall effectiveness and acceptability of the formulation. Their selection is not merely supportive but central to the success of patient-centric drug design, especially in pediatric and geriatric patients and those with swallowing difficulties.

 (e.g., purified water, glycerin, propylene glycol) are essential for dissolving the API in solution-based formulations. They influence the bioavailability and absorption rate of the drug (10). For poorly water-soluble drugs, co-solvents or solubilizers like polyethylene glycol may be used to enhance solubility (11).

, such as xanthan gum and colloidal microcrystalline cellulose—which is a co-processed excipient comprising microcrystalline cellulose (MCC) and sodium carboxymethyl cellulose (NaCMC)—help maintain uniform distribution of insoluble particles in suspensions. These agents prevent sedimentation and also ensure dose uniformity, which is critical for accurate dosing (10). The inclusion of the right amount of suspension aid can be a delicate balancing act between good suspension properties without being overly viscous. One case study involving an oral reconstitutable azithromycin suspension showed that inadequate amount of suspension aid (xanthan gum) led to inhomogeneity (phase separation), while inclusion of too much suspension aid rapidly increased the suspension viscosity (12).

 (e.g., antioxidants like sodium metabisulfite, chelating agents like ethylenediaminetetraacetic acid, preservatives like sorbic acid, and surfactants like polysorbates) protect the formulation from degradation due to oxidation, hydrolysis, or microbial contamination. Without stabilizers, the shelf life and efficacy of the product can be significantly compromised (10). These also need to be included in sufficient quantities to be effective. When sodium benzoate was included at less than 0.05% w/w in a topical formulation, the samples did not pass the 

 (e.g., sucrose, sorbitol, artificial flavors) are crucial for masking unpleasant tastes, especially in pediatric formulations. Palatability, especially poor palatability, directly affects adherence to treatment regimens. Inadequate taste masking can lead to poor compliance and therapeutic failure (10,14).

If key excipients are omitted or improperly selected, consequences can occur. For example, the API may precipitate, leading to inconsistent dosing. The formulation may degrade faster, reducing efficacy (and possibly unintended side effects). Microbial growth may occur in liquids without preservatives. Omitting taste modifiers could result in non-compliance. Ultimately, excipients are not just inert ingredients—they are functional components that ensure the drug product is safe, effective, and acceptable to the patient (10).

Rheological performances of suspension aids or agents, such as gel-like structure, thixotropic property, viscosity profile, and stability, are crucial to the successful development of a suspension formulation. Colloidal MCC is a great example of a suspension aid with ideal rheological performance. When activated in water, colloidal MCC forms a thixotropic gel-like structure that can be stable for months. The thixotropic behavior means it can flow easily under shear stresses, like pouring out of a bottle, and slowly regains its structure or viscosity upon removal of the stress (i.e., storage). The colloidal MCC can be used for both pre-made liquid suspensions (like Avicel RC-591) or reconstitutable suspensions (like Avicel CL-611).

Other common excipients used as suspending aids are xanthan gum and NaCMC. Xanthan gum is a high molecular weight polysaccharide produced by the fermentation of glucose or sucrose by various strains of the bacterium 

. Its ability to make highly viscous solutions at low concentrations makes it amenable to suspensions. NaCMC is an anionic polysaccharide produced by chemically modifying cellulose to make it soluble in water. The functional properties of NaCMC are able to be modulated by changing the substitution on the cellulose backbone and the molecular weight. Both xanthan gum and NaCMC can be used to increase the viscosity of a solution, thus helping to keep insoluble particles suspended.

The following case studies highlight colloidal MCC, xanthan gum, and NaCMC when used as suspension aids. Colloidal MCC often demonstrates better suspension performance than xanthan gum and NaCMC, including shelf stability (case study 1). However, such conditions as low pH and high salt content are shown to stress colloidal MCC suspensions, leading to flocculation. Combinations of suspending aids are able to overcome some of these challenges, as highlighted in case studies 2 and 3.

Suspension case study 1: impact of suspension aid selection

In case study 1, the suspension capability of colloidal MCC, in both pre-made liquid and reconstitutable suspensions, was compared with that of xanthan gum and NaCMC in a paracetamol (2.4 wt%) model suspension. Paracetamol (acetaminophen) is a common active ingredient used in suspension formulations. Each of the suspension aids was added at recommended levels to achieve good suspension properties: 1.2 wt% for the pre-made liquid suspension, 2.4 wt% for the reconstitutable suspension, 0.5 wt% for xanthan gum (GRINDSTED 80 PRM Plus or Clear 80 PRM) and 0.5 wt% for NaCMC (TEXTURECEL 20,000 PA 07). The remainder of the formulation components (paracetamol, polysorbate 80, Lycasin 80/55, sodium benzoate, phenoxyethanol) were kept at constant concentrations (quantum satis water). The suspension formulations were evaluated for pH, rheological properties, sedimentation, and stability (up to four weeks at room temperature).

The pre-made liquid and reconstitutable suspensions exhibited thixotropic behavior (

) with a strong gel-like structure, while the suspensions with xanthan gum showed only some thixotropic behavior and moderate gel-like structure. The suspension that contained NaCMC did not have any thixotropic and gel-like characteristics. These different rheologic properties led to different suspending capabilities. As displayed in 

, the premade liquid and reconstitutable paracetamol suspensions were the most stable formulations after four weeks of storage, as measured by the TURBISCAN stability index (TSI). The TSI corresponds to the cumulative sum of all backscattering or transmission variations of the entire sample due to destabilization over time—and accordingly, the higher the value, the more unstable the sample (15,16). They possessed the lowest TSI, resulting in stability rankings of “A+” and “A,” respectively. TSI of suspensions with xanthan gum were ranked “C.” The formulation with NaCMC was not stable and ranked “D.”

 Thixotropy of suspension formulations upon storage. NaCMC did not exhibit thixotropic behavior.

 TSI and images (inset) of suspensions at four weeks.

Colloidal MCC, in pre-made liquid form, makes a strong and stable suspension, but has its limitations. Two conditions can destabilize the colloidal MCC structure: low pH and high salts. Adding a protective colloid to the formulation can often overcome these issues, as highlighted in the next two case studies.

Suspension case study 2: overcoming low pH

Acidic components, like citric acid, may be added to suspensions for many reasons:

to improve stability and/or solubility of an API or other components

to attempt to mask bitter flavor with more pleasant flavor

to reduce pH and aid in the prevention of microbial growth in the formulation

to buffer the formulation to resist changes to pH.

Low pH formulations are particularly challenging to suspensions using colloidal MCC, as it flocculates out. The suspension images below contain ibuprofen (2 wt%) formulations with citric acid anhydrous added to the formulation to modify the pH of the suspensions to approximately 2.7, below the recommended pH levels for colloidal MCC. After four weeks at room temperature, the pre-made liquid colloidal MCC sample was observed to have a visible aqueous layer on top (

). The TSI was higher for that suspension (5, “C”) than the reconstitutable one (1.3, “B”), all indicating the pre-made liquid suspension was flocculating. The reconstitutable suspension showed moderately good stability (grade “B”) over the four weeks and could be an option for low pH suspensions.

 TSI for colloidal MCC and combination of colloidal MCC with xanthan gum under low pH conditions.

To overcome flocculation challenges of the pre-made liquid colloidal MCC suspension at low pH, a protective colloid can be added to the formulation. Xanthan gum (Clear 80 PRM) was added at 0.2 wt% to the pre-made liquid colloidal MCC formulated suspensions and showed stability improvements over those without xanthan gum (

). With xanthan gum, the suspension was stable for the full four-week test period at room temperature. One potential downside of adding xanthan gum is the significant increase in suspension viscosity: Without xanthan gum, the set-up viscosity of the suspension was about 250 cP (Brookfield at room temperature, spindle #3, 20 rpm) and increased to 700 cP with the addition of 0.2 wt% xanthan gum.

Suspension case study 3: overcoming high salt content

Salts may be added to suspension formulations for many reasons. They can be used as buffers to maintain a pH that is amenable to the API, and they can enhance absorption through mucosa (for nasal administration). Too much salt can cause the pre-made liquid colloidal MCC to flocculate and lose stability over time. Addition of a protective colloid, like xanthan gum, can restore the suspending powers of the formulation and maintain them throughout storage. The example here shows how incorporating calcium chloride (CaCl2) at concentrations from 0.5 to 1.5 wt% causes flocculation of the pre-made liquid paracetamol formulation after four weeks of room temperature storage (

). Adding 0.2 wt% xanthan gum (Clear 80 PRM) to the formulation with the highest salt content stabilized the suspension (TSI of “A”), even monitored out to four weeks (

 Colloidal MCC (pre-made liquid) formulated suspension images with increasing salt content at one week (a) and four weeks (b).

 TSI for colloidal MCC (premade liquid) with high salt content and the impact of adding a protective colloid. Images of suspensions (insert).

The above case studies highlight the importance of excipient selection on the stability of a suspension formulation. It is equally important to both identify and understand how to overcome any limitations of those excipients. Advancements in formulation technologies are paving the way for more effective and patient-friendly liquid medications. Such techniques as nanotechnology, microencapsulation, and lipid-based delivery systems are being explored to enhance drug solubility, stability, and bioavailability (17).

The role of liquid medicines is poised to expand significantly as accessibility and personalization become even larger drivers. The number of patients who need more accessible dosage forms is increasing. The proportion of the world’s population older than 60 will nearly double between 2015 and 2050, from 12% to 22% (18). In populations with swallowing difficulties, dosage form and flexibility are paramount. Stability, taste, and reliable and accurate dosing are also important for pediatric populations, as they often have difficulties taking medicine. A 2021 survey of 1172 children in several European countries identified liquid as the most favored dosage form overall, especially for kids aged 12 and younger (19).

Liquid oral drug delivery systems offer significant benefits in patient-centric development, addressing such challenges as ease of administration, flexible dosing, improved compliance, and faster onset of action. With ongoing innovations and a focus on personalized medicine, liquid medicines are positioned to not only be more effective, but also ensure vulnerable populations receive the right treatment in the right form at the right time. Timing is everything.

1. van Dulmen, S.; Sluijs, E.; van Dijk, L. et al. Patient Adherence to Medical Treatment: A Review of Reviews. 

Guidance for Industry, FDA Staff, and Other Stakeholders, Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

 (CDER, February 2022).
3. Almeida, I. F. Patient-Centric Drug Product Design: Case Studies for Special Populations. 


4. Denarié, M.; Gyzen, M.; Hegde, A. et al/IQVIA, “2024 Safety and Regulatory Compliance Trends and Predictions for Pharma and Biotech,” Whitepaper, Jan. 2, 2024.
5. Gascon, L.; Belfiglio, M.; Nowacki, A. S. et al. Prevalence of Self-Reported Voice and Swallowing Complaints in An Outpatient Geriatric Population. 


6. Inamoto, Y. and Kaneoka, A. Swallowing Disorders in the Elderly. 


7. Brady, P.; Miño, M.; Johns, S. et al/IQVIA, “2025 Safety and Regulatory Compliance Trends and Predictions for Pharma and Biotech,” Whitepaper, Dec. 18, 2024.
8. Malunjkar, D. D.; Maru, A. D.; Surana, S. S. et al. Pharmaceutical Suspensions: An Updated Review for Patient Compliance with Oral Dosage Forms. 

, 10 (1) 429–445.
9. Limenh, L. W.; Tessema, T. A.; Simegn, W. et al. Patients’ Preference for Pharmaceutical Dosage Forms: Does It Affect Medication Adherence? A Cross-Sectional Study in Community Pharmacies. 


10. Moreton, R. Commonly Used Excipients in Pharmaceutical Suspensions. In 

Pharmaceutical Suspensions: From Formulation Development to Manufacturing

, 1st ed.; Kulshreshtha, A. K., Singh, O. N., and Wall, G. M., Eds.; Springer, New York, 2010; pp. 67–102. DOI: 


11. Schneider, R.; Taspinar, L.; Ji, Y.; and Sadowski, G. The Influence of Polymeric Excipients on Desupersaturation Profiles of Active Pharmaceutical Ingredients. 1: Polyethylene Glycol. 


12. Sonawane, D.; Chaudhari, P.; Thorat, V.; and Dhavale, S. Quality by Design Approach for Development of Azithromycin Oral Reconstitutable Suspension and Its Comparison with Marketed Product. 

, 7 (2) 431–440.
13. Om, S. and Amol, K. Effect of pH on the Efficacy of the Sodium Benzoate as Antimicrobial Preservative in Topical Formulation. 

, 2018 (2) 64–67.
14. Ranmal, S. R.; Walsh, J.; and Tuleu, C. Poor-Tasting Pediatric Medicines: Part 1. A Scoping Review of Their Impact on Patient Acceptability, Medication Adherence, and Treatment Outcomes. 

, accessed Sept. 24, 2025.
16. Sun, Y.; Deac, A,; and Zhang, G. G. Z. Assessing Physical Stability of Colloidal Dispersions Using a Turbiscan Optical Analyzer. 


17. Alqahtani, M. S.; Kazi, M.; Alsenaidy, M.; and Ahmad, M. Z. Advances in Oral Drug Delivery. 


18. World Health Organization. Ageing and Health. 

, Oct. 1, 2024 (accessed Sept. 24, 2025).
19. Alessandri, E.; Brako, F.; Scarpa, M. et al. Children’s Preferences for Oral Dosage Forms and Their Involvement in Formulation Research via EPTRI (European Paediatric Translational Research Infrastructure). 

 is Global Strategic Marketing Manager, and 

Patient-centric drug development prioritizes patient needs, experiences, and preferences, enhancing treatment adherence and outcomes. Regulatory bodies like the FDA support this approach, emphasizing patient input in drug development. Special populations, such as pediatric, geriatric, and dysphagic patients, face unique challenges with medication intake, necessitating patient-friendly drug delivery formats. Liquid suspensions are gaining popularity due to their ease of administration and flexible dosing. Technological advancements, including nanotechnology and taste masking, improve liquid formulations' stability and palatability, enhancing patient compliance and treatment efficacy.

The growing demand for liquid medicines is increasingly driven by the unique needs of several distinct patient groups, improving compliance in these demographics through flexible, palatable dosing options.

Enhancing Patient-Centric Care Through Oral Liquid Drug Delivery Formulations

Glowing helicobacter pylori bacteria cells on dark blue background. Gastritis disease. 3d-rendering | Image Credit: © ecrow - stock.adobe.com

’s fixed-dose oral capsule marketed as Talicia, which combines the antibiotics amoxicillin and rifabutin and the proton pump inhibitor omeprazole, has been licensed for new Middle East markets in an agreement worth up to $1.8 million, plus sales royalty payments (1). RedHill, which has corporate headquarters in Tel Aviv and a United States hub located in Raleigh, NC, announced the deal on Oct. 6, 2025.

, and why does this treatment fill a need?

The all-in-one, low-dose rifabutin-based therapy is the only one of its kind approved by FDA that addresses resistance to other antibiotics commonly used to treat the bacterial infection 

, which is a key risk factor for gastric cancer. According to RedHill, gastric cancer causes approximately 800,000 deaths per year globally; however, eradication of 

 could lead to a 75% decrease in gastric cancer risk (1).

In a press release announcing the agreement, RedHill said 

, classified by the World Health Organization as a Group 1 carcinogen, affects approximately 35% of the US adult population, with an estimated 1.6 million people treated annually, rising to 50% worldwide and nearly 80% in parts of the Middle East (1). The infection is also a major risk factor for peptic ulcer disease and gastric mucosa-associated lymphoid tissue lymphoma.

 eradication is known to have a potential major impact on gastric cancer and other risks, current therapies fail in anywhere between 25% and 40% of patients, who remain 

-positive because of the bacteria’s high resistance to antibiotics, including the standard therapy clarithromycin (1).

What could this agreement mean for global expansion of other treatments?

A strategic licensing agreement for specialized treatments such as this illustrates a global trend toward leveraging regional partnerships to secure non-dilutive revenue streams while targeting specific disease hotspots. It suggests a template for expanding other innovative therapies aimed at infectious diseases, particularly those known to be major risk factors for cancer. Addressing high-prevalence areas, such as the Middle East where 

 rates approach 4 in 5, demonstrates how targeted market building can fulfill significant unmet medical needs globally.

The broader global landscape demands diversified therapeutic strategies against complex conditions like gastric adenocarcinoma. This involves the concurrent advancement of both large biologic immunotherapies, which are rapidly expanding into curative-intent, earlier-stage disease settings, and novel small-molecule approaches. Small-molecule immuno-oncology agents, for example, offer potential synergy with existing biologics by targeting non-traditional immune pathways. For any modality to succeed internationally, the necessity for robust evidence standards and operational readiness is paramount, whether for a complex fixed-dose combination therapy or large biologic under priority review, based on thorough chemistry, manufacturing, and controls planning and data integrity from before the investigational new drug phase through commercial readiness.

Are other gastric cancer treatments available?

RedHill’s development of Talicia goes back more than a decade; 

 the company reached an agreement under which 

 took manufacturing responsibility for the remaining supply of clinical trial material, and future commercial supply, for what was then a late-stage candidate known as RHB-105 (2).

’s supplemental Biologics License Application for Imfinzi (durvalumab) in combination with chemotherapy for perioperative treatment of adults with resectable Stage II–III gastric or gastroesophageal junction (GEJ) adenocarcinoma, with a Prescription Drug User Fee Act date set for the fourth quarter of 2025 (3). Meanwhile, gastric or GEJ adenocarcinoma is 

 in a Phase IIa clinical trial being conducted by 

 and Cancer Research UK for HTL0039732/NXE0039732, an investigational small-molecule immunotherapy drug from Nxera (4).

The patent for Talicia is protected through 2042 and, in the US, the treatment received eight years of market exclusivity following its November 2019 FDA approval via a Qualified Infectious Disease Product designation (1).

RedHill Biopharma Signs New $1.8 Million Plus Sales Royalties Middle East Deal for Talicia.

 Press Release. Oct. 6, 2025.
2. Recipharm. 

Recipharm Signs Agreement with RedHill Biopharma for Manufacturing of RHB-105 for Treatment of 

 Press Release. Aug. 26, 2025.
3. Cole, C. 

AstraZeneca’s Imfinzi Advances in Gastric Cancer with FDA Priority Review.

Cancer Research UK Partners with Nxera on Next-Stage Trial for HTL0039732.

RedHill Biopharma's Talicia, a fixed-dose oral capsule combining amoxicillin, rifabutin, and omeprazole, has been licensed for new Middle East markets in a $1.8 million deal, plus royalties. Talicia is the only FDA-approved therapy addressing antibiotic resistance in treating Helicobacter pylori, a significant gastric cancer risk factor. H. pylori affects 35% of the US adult population and up to 80% in parts of the Middle East. The agreement highlights a trend toward regional partnerships for non-dilutive revenue and targeted disease hotspot strategies.

The licensing of Talicia, an FDA-approved fixed-dose therapy, to key at-risk markets strategically combats an increasingly high antibiotic resistance to the cancer-causing bacteria.

RedHill's $1.8M Middle East Deal Signals Global Demand for Effective H. pylori Treatment

Targeted Alpha Therapy as a cancer treatment in clinical trials as a oncology therapies targeting malignant tumors with radioactive particles destroying cells | Image Credit: ©freshidea -stock.adobe.com

On Sept. 11, 2025, Medicines Discovery Catapult (MDC), a national life sciences service dedicated to drug discovery, and Crown Bioscience, a contract research organization, announced the companies were collaborating on an integrated translational biology platform for the development of radiopharmaceuticals (1). As part of the collaboration, MDC will provide knowledge in cell biology, high-resolution microscopy, radiochemistry, preclinical imaging, mass spectrometry, and multi-omic tissue analysis, and Crown Bioscience will provide discovery, preclinical, and translational platforms and services for oncology and immune-oncology products.

To find out more about this collaboration, 

® spoke with Juliana Maynard, PhD, Head of Translational Imaging, at Medicines Discovery Catapult, to find out what makes radiopharmaceuticals unique and how MDC’s collaboration with Crown Bioscience can help developers of these treatments for cancer.

 What is unique about the use of radiopharmaceuticals to treat cancer?

Radiopharmaceuticals really do have enormous potential in modern medicine. They're already driving game-changing breakthroughs to patients, and we're seeing that worldwide. At their core, they are a class of medicines that contain both a radioactive form of a chemical element, something we call a radioisotope, and they can be used to both diagnose and also to treat cancers.

But what makes them so unique and so powerful is their precision; they will target radiation directly to the tumors. They work by taking a targeting molecule that binds to a specific receptor on a cancer cell and carries the radioisotope straight to the disease site. And once it's there, the gamma rays will emit either alpha or beta particles and kill the cancer cells for therapy. This means that we can both see the disease through the diagnostic tracer, and we can also treat it in a very targeted way, something we call a theranostic approach. It's highly individualized, and it's very much image-guided therapy. So instead of a one-size-fits-all [approach], what we can do is get a smarter, safer, and more patient-derived, stratified medicine approach to treatment.

Compared with traditional cancer therapies, radiopharmaceuticals spare healthy tissue. We don't get those side effects that we've seen with other cancer medicines, and because they're so precisely delivered to the cancer cells, the radiation dose to the rest of the body is significantly reduced, which lowers the risk of side effects. And we've shown proven treatment effects already in some really difficult-to-treat cancers. For example, prostate cancer and neuroendocrine tumors have shown huge traction.

Beyond the therapy, those radioactive traces and the technology advancements that we're seeing within the United Kingdom provide incredibly detailed insights to give both earlier and more accurate diagnostics. What makes them so unique is that we can combine the diagnosis and the treatment into one, and we're offering earlier detection [and] better, more precise treatment, [which] ultimately, should lead to better patient outcomes.

Challenges associated with radiopharmaceuticals

Radiopharmaceuticals offer a unique, targeted approach to cancer treatment by delivering radiation directly to tumors, minimizing damage to healthy tissue and reducing side effects. The collaboration between Medicines Discovery Catapult (MDC) and Crown Bioscience aims to accelerate the development of these therapies through an integrated translational biology platform. This partnership addresses challenges such as isotope supply, regulatory requirements, and logistical issues. By combining expertise in imaging, radiochemistry, and preclinical models, the collaboration seeks to enhance precision medicine strategies and improve patient outcomes.

Pharmaceutical Technology® spoke with Juliana Maynard, PhD, Head of Translational Imaging at Medicines Discovery Catapult, to find out what makes radiopharmaceuticals unique and how MDC’s collaboration with Crown Bioscience can help developers of these treatments for cancer.

Featured Content

Behind the Headlines Episode 25

Ask the Expert

Drug Digest September 2025

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains

Stakeholders React to FDA's Push for Quality, Integrity, and Uniformity