Formulation

Solid dispersions based on organic polymers can have stability issues. Inorganic solids, especially those based on silica chemistry, may be suitable alternatives to organic polymers due to their pre-formed pore system, high absorptivity, and commercial availability in pharmaceutical quality. Mesoporous granulated colloidal silicon dioxide has been studied with class II and IV actives of the Biopharmaceutics Classification System for its ability to improve dissolution. Using suitable formulation strategies, the dissolution of these APIs could be significantly increased. The absorption of poorly soluble APIs onto silicon dioxide can, therefore, be considered a viable formulation path to overcome solubility challenges.

A case study reviews the reformulation and scale up of high drug load prototype using wet granulation process for a model formulation.

The newly installed Harro Hӧfliger encapsulation unit expands Capsugel’s clinical- and commercial-scale capacity for dry powder inhalation projects.

Effective solutions for overcoming the high molecular weight, hydrophilicity, and instability of large biomolecules have yet to be identified.

This study investigated the stability of solid lactose stored under high temperature and humidity conditions.

The authors discuss the challenges of capsule filling in preclinical and clinical studies.

Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity.

More agile techniques are improving the development of multiparticulate drug-delivery systems.

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.

Hot-melt coating was used to develop taste-masked orally disintegrating granules of acetaminophen and caffeine.

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

The new facility will focus on formulation development, drug product analytical development, and quality control.

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.

Capsugel’s intrinsically enteric capsule technology provides enteric protection and delayed release without a functional coating. Merck’s Parteck SRP 80 sustained-release excipient is well suited for direct compression.

The OptiForm Solution Suite platform offers easy, simple, fast, and cost-effective approaches for both small and macromolecules in early development phases.

This article will equip the excipient vendor with an understanding of QbD from the perspective of the topical pharmaceutical product manufacturer.

Excipients play a crucial role in the manufacturing of solid-dosage forms and the performance of the finished drug product.

Understanding the components of a reference marketed pMDI is needed to develop a generic pMDI.

Nanoparticulate technologies are showing promising potential in delivering both small-molecule drugs and biomacromolecules across the blood brain barrier.

One of the major challenges in working with excipients today is understanding, and adjusting to, complexity in materials and formulations.

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

Analytics and science-based approaches are shedding more light on these complex dosage forms, promising to improve process control and product design.

The authors review the regulatory changes associated with the use of dimethyl sulfoxide in finished pharmaceutical dosage forms.

The GMP-certified facility will produce TruTag microtags for global pharmaceutical customers.

Researchers at the ARC Centre of Excellence in Convergent Bio-Nano Science (CBNS) in Melbourne, Australia have developed a drug-delivery technology that circumvents first pas metabolism in the liver, thereby, enabling higher drug levels to reach the systemic circulation.

Industry experts discuss key considerations in the development of orally disintegrating tablets.

CPhI Pharma Awards seek nominations for excellence in development and manufacturing.

Polymers have played a key role as solubilizing excipients. Industry experts explain why polymer structures and functionalities are important considerations in formulation development.