Dosage Forms

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

Customers are looking to reduce risk, increase performance, and optimize productivity.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Experts from Capsugel and Catalent discuss the rationale of using lipid0basd formulations to improve the oral bioavailability of poorly soluble drugs.

With a number of branded biologics hanging at the patent cliff, the future looks promising for biosimilars.

Innovative therapeutic approaches beyond mAbs will require new methods for future facility construction.

Tool coatings are now seen as an acceptable means of solving production problems, such as sticking and corrosion, resulting in increased product yield.

Efforts to tackle challenges in tablet manufacture are shaped by quality by design (QbD) and continuous manufacturing.

To realise the full potential for biosimilars, stakeholders must build a better understanding of biosimilars and to take a comprehensive view of how these important medicines can fit into treatment pathways.

Stephen Tindal from Catalent Pharma Solutions speaks with Pharmaceutical Technology Europe about advances in softgel technologies.

Softgels are now being recognised as one of the preferred dosage forms for the treatment of pain, eye conditions, cough and cold, as well as allergy.

Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

Contract development and manufacturing organizations identify trends, challenges, and emerging technology and service needs for solid and semi-solid dosage forms.

Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.

Redbiotec and GE Healthcare Life Sciences develop a novel manufacturing process for virus-like particles.

The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

Study provides first substantive reference data on key quality attributes of empty capsules

Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

American Health Packaging announced a voluntary nationwide recall of ibuprofen and oxcarbazepine tablets due to mislabeling on the inner unit dose blister packaging.

New International Council on Biotechnology Associations advocates biotechnology growth.

Fette's FE75 Tablet Press is designed for large batches.

Kraemer KD60 equipment conveys and dedusts vitamin and nutraceutical tablets.

Several groups, including pharmacies, call on FDA to preserve accepted International Nonproprietary Name conventions for biosimilars.

Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

Jones Packaging introduces a new solid dose vial line in its Toronto facility.

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

Funding boosts life-sciences manufacturing in West Michigan.

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.