Excipients

Biologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.

Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.

Excipient purity is critical in all applications of drug formulation. Typically, the more sensitive or reactive an API, the more critical excipient purity becomes.

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.

The authors present an update to the Wyeth/BASF experience with the IPEC Novel Excipient Safety Evaluation Procedure.

The author explains the background behind the excipient pedigree and how to implement its use.

FDA chemistry reviewers in the Office of Generic Drugs provide an overview of common deficiences cited throughout the Chemistry, Manufacturing, and Controls section of ANDAs.

Excipient manufacturers expand their products, services, manufacturing capacity, and technology positions.

Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.

Agreement on standards for excipient qualification, development, and fair pricing is underway.

A Technical Forum featuring representatives from Dow Chemical, ISP, and DMV-Fonterra Excipients. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The author describes the new IPEA excipient good-manufacturing-practice certification program that is now ANSI accredited. This article is part of a special issue on excipients and solid dosage.

The authors review new regulatory expectations and describe potential approaches to accommodate excipient variability. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

A Q&A with the First Federation Chair, Patricia Rafidison.

It's time to maintain a thorough traceable excipient trail.

The authors discuss a study that demonstrates the use of polyethylene oxide mixtures to investigate the effect of polymer viscosity on formulation robustness.

In response to a request from the FDA, the US Pharmacopeial Convention (USP) has revised its standards for propylene glycol and sorbitol solution, excipients widely used in prescription and over-the-counter drugs.

In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution

The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment.

The authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.

USP workshop participants support new methods to safeguard heparin products but desire international harmonization. This article contains bonus online-exclusive material.

IPEC's new stability testing guide takes into account the full supply chain's storage conditions.

Parteck ODT is a newly introduced ready-to-use excipient for fast melt tablets.

The US Pharmacopeia is revising its monographs for four pharmaceutical excipients: propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystalllizing sorbitol solution.

The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.

The authors investigate whether the addition of an antioxidant could be used to stabilize the solvent ethyl lactate by preventing the formation of peroxides

The GDP committee of IPEC–Europe is trying to seal one more broken link in the supply chain. This article contains bonus online-exclusive material.

2009 Post-Interphex Showcase: Chemicals

A review of recent product innovations, policy developments, and growth prospects in the excipients market.

Without any GMP guidelines for excipients in Europe, change can't come soon enough for some industry groups.