Dosage Forms

Tino Otte is senior consultant at Intertek, tino.otte@intertek.com, Tel: +41 (61) 686 48 56.

Articles

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


Extractables and Leachables Testing for Inhaled Medicines

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 to Manufacture Lexicon Pharmaceuticals' Orphan Drug Xermelo

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.

Manufacturing and Formulation Solutions for Inhaled Dose Forms

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

Nemera Joins European Project to Develop Inhaled Nanoparticles for Heart Disease

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.

EMA Grants Orphan Drug Designation to Epidiolex for Treatment of Lennox-Gastaut Syndrome

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

EMA Recommends Three Orphan Drugs for Approval

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

Orphan Drug Natpar Receives EMA Recommendation

EAG Laboratories offers dermal absorption studies using OECD methods.

EAG Laboratories Adds Capabilities in Dermal Absorption Testing

David W. Osborne, PhD, is Chief Scientific Officer and Founder, Independent Derm Solutions, LLC, 4215 Creekside Court, Fort Collins, CO 80525.

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.

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

The Intelligent Control Inhaler is an intuitive, fully-integrated device delivering accurate doses of medication to patients, while providing on-screen instructions for use and feedback to the patient and healthcare provider via an app.

Specialty Dosage Drugs