Pharmaceutical Technology Editors

Lonza announced on Nov. 1, 2022 the launch of a new capsule solution for intestinal drug delivery called Capsugel Enprotect. The capsule does not disintegrate during stomach transit and only releases its contents in the intestine. It is a coating-free capsule that may be able to simplify the drug manufacturing process by mitigating the need for additional capsule coating or sealing.

According to a company press release, the recent innovations made my Lonza may be able to address changing patient needs while meeting regulatory requirements for multiple pharmaceutical and nutraceutical applications.

“This new capsule technology has the potential to make significant improvements to oral drug delivery. With its proven protection in acidic environments, Capsugel Enprotect provides drug developers with a viable oral solution to deliver novel therapies to the distal small intestine, including live biotherapeutic products, small and large molecules, and oral vaccines,” said Christian Seufert, president, capsule & health ingredients, Lonza, in the release.

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Lonza has launched a new capsule to deliver acid-sensitive APIs to the intestine. 

Lonza Launches New Capsule Solution for Intestinal Drug Delivery

The US Pharmacopeia (USP) published revised general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, on Nov. 1, 2022. USP’s Compounding Expert Committee has made these changes as a result of the evolving practice of compounded medicine and current scientific evidence, according to the organization. The revised chapters clarify misunderstood topics and include input from more than 1400 comments received during the public comment period. The changes become official on Nov. 1, 2023.

“The revisions to <795> and <797> will significantly advance compounding quality, accounting for the realities of pharmacy practice and the needs of patients. Some specific updates to chapter <795> include recommendations and requirements for facilities and equipment, minimum frequencies for cleaning, and more information about the protective garb that personnel wear. Among the changes to chapter <797>, there are updates to labeling requirements and the frequency of surface contamination testing based on the products being compounded,” the organization said in an interview with 

A robust scientific and risk-based approach to the assignment of beyond-use dates (BUD) for compounded medicines is also included in the revised chapters. BUD is the date after which a compounded medicine cannot be used, according to USP. “This approach allows for longer beyond-use dates under certain circumstances, while still aiming to protect patients from the potentially dangerous consequences when ingredients breakdown or harmful microbials emerge over time,” USP said in the interview.

While the chapters become official one year after publication, USP encourages stakeholders to implement the new requirements and recommendations early and take advantage of the resources the organization provides. More information can be found at 

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

USP Revises Drug Compounding Chapters

Ashland announced on Oct. 31, 2022 that FDA’s Center for Drug Evaluation and Research’s Office of New Drugs has accepted Ashland Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient in the review cycle of the FDA Novel Excipient Review Pilot Program.

This is the first time FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations. The program offers a new pathway to evaluate excipients and could quicken important public health benefits. Ashland’s excipient is intended as a polymeric carrier for the delivery of therapeutic pharmaceuticals to target certain tissue sites within the body.

“This prestigious opportunity to participate in the FDA pilot program shines a spotlight on Ashland’s life sciences core strategy of undiluted attention to innovation in pharmaceutical ingredients,” said Ashok Kalyana, senior vice-president and general manager, life sciences, Ashland, in a company press release. “Working with pharmaceutical partners, we’re addressing scenarios where manufacturers and drug developers have previously cited difficulty using existing products. Ashland’s innovative excipients effectively deliver complex drug molecules whereand when they're needed.”

FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program. 

Ashland Injectable Pharmaceutical Excipient Accepted into FDA Novel Excipient Review Pilot Program

Gerresheimer announced on Oct. 26, 2022 that is has developed a new dropper insert, DropControl, for use with modern ophthalmic drugs that have low viscosity. The company is showcasing the product at its booth during CPHI 2022, which is being held in Frankfurt, Germany, on Nov. 1–3, 2022.

To address the needs of an aging population with eye diseases, as well as current trends in a workforce that relies heavily on screens and monitors, pharma companies have developed new ophthalmic treatments. This new generation of eye drop solutions have modified properties that improve the efficiency and pharmaceutical effectiveness of the treatment. For such eye-drop formulations, however, the function of a conventional eyedropper requires a modification to prevent uncontrolled dropping during use, according to a company press release.

“With DropControl, Gerresheimer offers a solution to enable the use of conventional eyedropper systems in combination with the new eye drop solutions with very low viscosity,” said Niels Düring, global executive vice-president at Gerresheimer Plastic Packaging, in the press release.

DropControl is designed such that the outer part of the pipette is changed slightly. The inner part has been given an insert that is connected to the outer part. The patient can apply the eye-drops as usual, and the insert prevents uncontrolled release of the droplets, according to the press release. DropControl is suitable for all of Gerresheimer´s A, E, and F dropper bottle systems in 5 mL, 10 mL, 15 mL, and 30 mL.

Gerresheimer has developed a new dropper insert for ophthalmic formulations that it is showcasing at CPHI 2022 in Frankfurt, Germany.

Gerresheimer Showcases DropControl, a New Dropper Solution for Ophthalmic Formulations, at CPHI 2022

Thermo Fisher Scientific will showcase its expertise, innovations, and capabilities to help pharmaceutical and emerging biotech companies via various modalities and platforms, including cell and gene therapies, oral solids, steriles, and biologics at CPHI Frankfurt 2022. Thermo Fisher experts will be available at CPHI Frankfurt 2022, Nov. 1-3, 2022, Booth #90J10, Hall 9.

"As pharma and biotechs look to transform molecules to medicines, they are looking for integrated solutions that connect the entire value chain from early development and clinical trials to scalable manufacturing and integrated sourcing," said Leon Wyszkowski, president of commercial operations, pharma services, Thermo Fisher Scientific, in a company press release. “This week, we will demonstrate our deep expertise across a range of topics — from clinical research and advanced therapies to digital technologies — to help our customers accelerate their innovation and speed the delivery of breakthrough medicines and therapies to patients.”

For more about Thermo Fisher sessions and activities at CPHl Frankfurt, visit 

Thermo Fisher Experts will demonstrate its various capabilities at CPHI Frankfurt 2022.

Thermo Fisher Scientific Showcases at CPHI Frankfurt 2022

Roquette, a global leader in plant-based ingredients and provider of pharmaceutical and nutraceutical excipients, announced on Oct. 31, 2022 the launch of two next-generation mannitol products for direct compression. The excipients are called PEARLITOL CR-H and PEARLITOL 200 GT and are designed to overcome unique drug formulation challenges and help manufacturers optimize direct compression processes, as well as expand into novel application areas.

PEARLITOL CR-H is a patented blend of mannitol and hydroxypropyl methylcellulose (HPMC) that allows for the sustained release of APIs in direct compression formulations. This may create new opportunities to enter the controlled-release drug delivery space, which typically requires wet granulation processes. The co-processed mannitol and HPMC brings other functional properties, such as flowability, to help optimize tablet processibility.

PEARLITOL 200 GT is a granulated mannitol excipient designed to enhance tableting performance. It addresses the capping and sticking issues that are common in other excipient solutions. It also facilitates the development of harder, smaller tablets that can be used in novel pharmaceutical applications, such as fast-dissolving medications.

Visitors are invited to join Roquette’s experts at CPHI in Frankfurt, Germany, on Nov. 1–3, 2022 at stand 80C90 to gain insights about their latest innovations.

Roquette has launched excipients PEARLITOL CR-H and PEARLITOL 200 GT.