Formulation and Drug Delivery

AstraZeneca Files Suit Against FDA; Pfizer, Biocon Terminate Biosimilar Alliance; and More.

BASi Restructures; Celerion, Ricerca Biosciences Form Biosimilars Alliance; and More.

The Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA), issued its support for the introduction of a House bill, the Generic Drug and Biosimilar User Fee Act (HR 3988), which SOCMA says will help to achieve parity between foreign and domestic firms.

GlaxoSmithKline and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan. The joint venture will seek to improve access to vaccinations in the Asian nation as well as introduce new vaccines.

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

Nanosupensions are among the ways formulation scientists seek to address the problem of solubility.

The divide between innovation and conflict of interest in medical research is not so clear.

Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.

In Part II of a three-part article, the authors examine impurities from chiral molecules, polymorphic contaminants, and genotoxic impurities.

Wirelessly controlled microchips may offer an alternative to injection-based drug delivery

SOCMA's Bulk Pharmaceuticals Task Force outlines key goals and challenges for user-fee legislation.

Has the long-awaited guidance answered all of the industry's questions?

The author reviews significant changes to GMP for excipients in the forthcoming American National Standard, including a risk-based approach to excipient manufacture, why new requirements were proposed, and their potential impact to excipient manufacturers.

This article provides guidance for industry on how to comply with the pending American National Standard on excipient GMP, with a focus on risk assessment.

This article considers the different conditions to which the powder is subjected in the tableting process, and discusses which powder properties should be measured to accurately reflect likely powder behavior in the process.

Pharmaceutical companies, equipment providers, contract-service providers, and excipient manufacturers apply various approaches for improving solubility. The article examines some recent developments.

Taste-masking is an important consideration to ensure patient compliance.

Experts in solid dosage discuss the formulation and manufacture of multilayer tablets.

The pharma industry has reached the long-dreaded patent cliff, but for copycat products, business is booming.

Boehringer Ingelheim's Heribert Häusler tells us about parametric release and real-time testing.

JHS Secures Four Sterile Parenteral Products Manufacturing Contracts; Samsung Biologics, Biogen Idec Establish Biosimilars Joint Venture; and More.

Pfizer has signed an agreement with the Chinese biopharmaceutical company Zhejiang Hisun Pharmaceuticals with the objective of establishing a $545-million joint venture to develop and commercialize branded generic medicines in both China and the global market.

The author discusses the relative advantages and disadvantages of lyophilization in vials and dual-chamber systems.

A nickel's worth of free advice to the competition could come at the expense of your bottom line.

A new class of nanoparticles hold promise for preventing premature drug release and offering greater accuracy and effectiveness in drug delivery.