Pharmaceutical Technology Editors

The new oral suspending base from PCCA, called SuspendIt Anhydrous, can be used on APIs that are unstable in water or are incompatible with existing aqueous vehicles, according to a company press release.

“An anhydrous base offers many benefits to compounding pharmacies,” said Gus Bassani, PCCA chief scientific officer, in the press release. “There’s no water to support the growth of micro-organisms or cause hydrolytic degradation of an API and it opens the potential for formulations to be assigned longer beyond-use dates (BUDs). But what makes our new base really unique is its self-emulsifying properties. This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility as well.”

Many anhydrous bases are oil-based; however, many patients do not like the taste of oil-based vehicles or the oily residue left in their mouths and throats. These highlighted issues along with other problems have led to problems with medication compliance.

“We developed a unique anhydrous base that, in addition to the self-emulsifying properties, has an improved viscosity, which reduces when shaken and thickens when standing. This thixotropic effect allows for rapid redispersion of APIs with agitation and minimizes sedimentation,” said Daniel Banov, PCCA director of Research and Development, in a press release. “We added a natural sweetener, as well as the ability to mix the compounded medicine with juice or water at the moment of administration, for a better taste if desired. The technology is so unique that we have a patent pending.”

PCCA has also created formulas for the most prescribed APIs and plans to continue formula development and API testing.

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This self-emulsifying system improves the miscibility and dispersibility of formulations in aqueous environments and may improve API solubility.

SuspendIt Anhydrous Introduced as New Compounding Base

Spectrum Laboratory Products announced on Jan. 9, 2023 that the company is voluntarily recalling three lots of epinephrine (L-Adrenaline) USP, a bulk API used to manufacture or compound prescription products to the user level.

The L-Adrenaline USP bulk API powder is used in manufacturing and compounding of finished-dose epinephrine prescription products that can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person. The use of a finished-dose product manufactured or compounded with the recalled product could result in less-effective product and incomplete treatment of life-threatening conditions, such as low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack. Further, treatment with a less-effective product or underdosing of epinephrine could result in death.

The main customer complaints have found that the product is discolored. The doses that are included in the impacted Epinephrine USP product can be identified by Spectrum catalog number EP130.

There have not been any reports of adverse events related to this recall, according to Spectrum Laboratory Products.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person.

Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

A FDA guidance was published on Jan. 4, 2023 that provides recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product and a biological drug product. A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

This guidance specifically provides recommendations to applicants on drafting proposed REMS documents and converting an already-approved REMS document to a new, standardized format that is clearer and more informative while supporting the submission of a REMS document in Structured Product Labeling format.

An overview of the types of information that should be included in a REMS document is provided in the new document, whereas additional and more detailed information is provided in a separate guide, titled 

REMS Document Technical Conformance Guide

, which will be updated periodically on FDA’s website.

The guide can be used for drafting a REMS document for single product and shared system REMS and includes an outline for drafting a Bifurcated4 REMS document.

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Updated REMS Document for Prescription, Biological Drug Product

AstraZeneca announced a definitive agreement to acquire CinCor Pharma, a clinical-stage biopharmaceutical company focused on developing novel treatments for hypertension and chronic kidney disease, on Jan. 9, 2023. The deal, worth up to $1.8 billion, grants AstraZeneca global rights to baxdrostat (CIN-107), a novel aldosterone synthase inhibitor (ASI) currently in development as a treatment to lower blood pressure in treatment-resistant hypertension. The deal is expected to close in the first quarter of 2023.

According to a company press release, CIN-107 is highly selective for aldosterone synthase and spares the cortisol pathway in humans. AstraZeneca will also acquire the rights to farxiga (dapagliflozin), another treatment designed to prevent and delay cardiorenal disease.

“Acquiring CinCor supports our commitment to cardiorenal disease and further strengthens our pipeline with [CIN-107],” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, in the press release. “Excess levels of aldosterone are associated with hypertension and several cardiorenal diseases, including chronic kidney disease and coronary artery disease and being able to effectively reduce this would offer a much-needed treatment option for these patients.”

“We are excited about the proposed acquisition of CinCor Pharma by AstraZeneca as we believe it offers the prospect of accelerating the development timeline and expanding the breadth of benefits patients with cardiorenal diseases might obtain from baxdrostat, if approved,” said Marc de Garidel, CEO, CinCor, in the press release. “CinCor is committed to ensuring a smooth transition of the development responsibilities to AstraZeneca once the acquisition is consummated.”

The definitive agreement will give AstraZeneca global rights to CinCor’s portfolio of cardiorenal disease treatments.

AstraZeneca Inks $1.8 Billion Acquisition for CinCor Pharma

Chiesi Farmaceutici, a research-focused biopharmaceuticals and healthcare group, and Amryt Pharma, a commercial-stage biopharmaceutical company focused on rare diseases, announced a definitive acquisition agreement on Jan. 8, 2023. Chiesi will acquire Amryt for approximately $1.25 billion, with an additional $225 million available in contingent value rights. The transaction is expected to close before the end of the first half of 2023.

“With this Transaction, we are further expanding our commitment to people living with rare diseases, the majority of which still have no cure or approved treatment,” said Marco Vecchia, CEO, Chiesi Group, in a company press release. “This addition of the Amryt portfolio, as well as their expertise, will help us on our journey to bring medicines to patients, no matter how rare their condition may be.”

“Chiesi is aligned with Amryt’s commitment and passion, and I believe Chiesi will further maximize the value of Amryt’s current portfolio and pipeline and most importantly, will accelerate our ability to reach more patients in need globally,” said Joe Wiley, CEO, Amryt Pharma, in the press release.

Chiesi will acquire Amryt Pharma, a commercial-stage biopharmaceutical company, in a deal worth up to $1.47 billion.

Chiesi Acquires Rare Diseases Company in $1.47 Billion Deal

Samsung Biologics announced on Jan. 11, 2023 that it has been awarded the Sustainable Markets Initiative’s Terra Carta Seal. The Seal was launched at COP26 by His Majesty King Charles III when he was Prince of Wales, and it recognizes global companies that are driving innovation and demonstrating their commitment to creating genuinely sustainable markets. It is being awarded to companies whose ambitions are aligned with those of the Terra carta, a recovery plan for Nature, People, and Planet, launched in January 2021.

Samsung is one of the 19 companies to have been awarded the 2022 Terra Carta Seal. The company affirmed its commitment to achieving net zero greenhouse gas emissions across its direct operations and supply chain by 2050 or earlier as part of its global response to climate change.

“We are honored to be recognized with the Terra Carta Seal by the Sustainable Markets Initiative for Samsung Biologics’ contribution in working alongside our industry peers for this global effort,” said John Rim, CEO and president of Samsung Biologics, in a company press release. “Healthcare is at a pivotal moment and through our collaborative efforts, we can contribute to shaping climate-resilient practices to influence and help shape policy across the pharmaceutical and healthcare sectors.”

The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future. 