Specialty Dosage Drugs

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

Nemera is now authorized to handle, assemble, sterilize, and store pharmaceutical drugs and medicinal products for autoinjector combination products at its facility in Neuenburg, Germany.

Considerations in selecting a dosage form for drug delivery to the lungs.

Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how-with the right knowledge and expertise-these challenges can be overcome.

Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine.

The Thermo Scientific Pharma mini implant line is built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Successful development requires coordinating and aligning drug and device design, focusing on a complete drug delivery system that meets patients’ needs.

The agency recommended a total of 11 drugs at its July meeting, including five orphan drugs.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The agency announced a plan to eliminate its existing orphan designation request backlog.

Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York.

At an industry seminar hosted by Leistritz Extrusion, experts explained the use of extrusion equipment to mix polymeric excipients with APIs for solubility enhancement and for multifunctional and specialty dosage forms, including implants.

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.

Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.

Catalent combines its formulation expertise, manufacturing excellence and particle size reduction technologies to provide a broad range of solutions in the development of inhalation and nasal drug products.

The project will foster the translation of nanomedicine applications for the treatment of cardiovascular diseases.

GW Pharmaceuticals plans to submit a regulatory filing to FDA and EMA following two positive Phase III trials of Epidiolex in patients with Lennox-Gastaut Syndrome.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

EAG Laboratories offers dermal absorption studies using OECD methods.

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.