Dosage Forms

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

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

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

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

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.

PDA organizes this conference to address the technical and regulatory issues related to parenteral packaging. Chemical, physical and microbiological aspects will be considered and current regulatory challenges will be discussed. Two Training Courses on Container Closure Development or Selection and Utilization of Glass Containers in Pharmaceutical Packaging will be given.

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.

Debottlenecking downstream mAb purification.

Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

The pharmaceutical majors advance vaccines for the developing world.

The authors designed an upper punch with a removable punch tip to determine a tablet formulation's propensity to stick by weighing the mass of powder adhered to the punch tip.

Challenges remain, particularly for early-stage biopharmaceutical companies.

Technology may expedite operations, but the absence of the human element could cost dearly.

Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.

Multilayer tablets can be challenging, but meeting regulatory expectations is crucial. We speak with Vilayat Sayeed from the FDA, to find out more about the critical factors that need to be fully understood.

Pfizer and GlaxoSmithKline have announced separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis, and is one of leading causes of death in children under the age of five in developing countries.

AstraZeneca Acquires Chinese Generic-Drug Company; Takeda Makes Management Changes; and More.

Pfizer and GlaxoSmithKline have announced separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries.

Last week, the US Department of Health and Human Services and Novartis Vaccines and Diagnostics dedicated a manufacturing plant that can create influenza vaccine using cultured animal cells instead of the conventional expression system of fertilized eggs.

Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung's latest effort to strengthen its position in biosimilars.

On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.

Biosimilar manufacturers need better expression systems and analytical tools to compete.

Pharma companies must balance demand for new drugs while facing reduced R&D spending.

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company's South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.

Small drug companies with hopes of achieving $1 billion in sales can pursue various strategies.

Biosimilar manufacturers need better expression systems and analytical tools to compete.