Formulation and Drug Delivery, Solid Dosage

Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.

Flexibility and well considered manufacturing approaches could help tablet manufacturers face the increasing pressure resulting from the shifting bio/pharma development landscape.

Market demand and regulatory guidance continues to promote improved medication design.

Laboratory testing found that a novel approach reduced the time required for sample preparation from hours to minutes. This article summarizes test methods and results.

Modified-release oral dosage forms can offer benefits to both formulation scientists and patients.

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.

The company’s planned investment in its alkoxylation facility in the United States Gulf Coast will also expand production capacity for its polyethylene glycols.

Lonza’s Capsugel Colorista capsule R&D solution can cut overall development time and offers greater flexibility during technical color development.

Innovative technologies, such as drug-loaded devices and 3D printing, enable advances in implantable devices and other novel dosage forms.

Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

Omya will showcase Omyapharm 500-OG (calcium carbonate and tribasic calcium phosphate) at CPhI Worldwide in Madrid, Spain, on Oct. 9–11, 2018.

3D printing is being explored as a manufacturing method for on-demand, personalized medicine.

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

Senomyx uses an approach, known as taste-blocking, to address the challenges of bitter APIs. Kenneth J. Simone, vice-president of Pharmaceutical Business Development, Senomyx, speaks with Pharmaceutical Technology about this technology.

The level of tastemasking required will depend on the API properties and the dosage form design.

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

The acquisition of Juniper expands and strengthens Catalent’s offerings in formulation development, bioavailability solutions, and clinical-scale oral dose manufacturing.

Pharmaceutical companies are developing new strategies to address the ever-increasing development costs for new drug therapies and maximize the value of their existing drug portfolio.

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.

API can be mixed with silicone and other polymers to create drug-delivery combination products.

The extension provides four additional process development laboratories at its Nottingham site to improve output and efficiency in drug development and clinical trial manufacturing operations.

New approaches enable more patient-centric drug design that offers improved outcomes.

The Natoli AIM Data Acquisition and Analytical Software for Natoli’s NP-RD10A single-station tablet press speeds research and development.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

The author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system.

Integration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.

Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.

Abuse-deterrent opioid formulations generally fall into two categories: the first is based on a physiochemical abuse-deterrent approach and the second combines the opioid with an antagonist.