title: Extemporaneously prepared controlled release formulations for accelerating the early phase development of drug candidates.
abstract: Extemporaneous drug preparations, which are compounded by a pharmacist at a clinical site, are commonly used in early clinical studies to evaluate the performance of drug candidates. However, the types of formulations compounded have been limited to relatively simple preparations such as solutions, suspensions and active ingredients filled into capsules. This article describes the preparation of advanced formulations, specifically extemporaneously prepared matrix tablets and osmotic capsules, which can be used to evaluate the feasibility of controlled release for exploratory new drug candidates or new formulations of existing drugs with a differentiated medical advantage. Extemporaneously prepared dosage forms enable the rapid assessment (i.e. reduced cycle time) of new formulation ideas with minimal quantity of the active pharmaceutical ingredient needed to demonstrate proof-of-concept.
authors.affiliation: Pfizer Inc., Center for Discovery and Development Sciences, Eastern Point Road, Groton, CT 06340, USA. Electronic address: avinash.g.thombre@pfizer.com.
authors.forename: Avinash G
authors.initials: AG
authors.lastname: Thombre
authors.affiliation: Pfizer Inc., Center for Discovery and Development Sciences, Eastern Point Road, Groton, CT 06340, USA.
authors.forename: Alfred
authors.initials: A
authors.lastname: Berchielli
authors.affiliation: Pfizer Inc., Clinical Research Unit, 1 Howe Street, New Haven, CT 06511, USA.
authors.forename: Janyce F
authors.initials: JF
authors.lastname: Rogers
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D003692:Delayed-Action Preparations / Q000138:chemical synthesis* / Q000378:metabolism; D004339:Drug Compounding / Q000379:methods; D055808:Drug Discovery / Q000379:methods*; D006801:Humans
chemical_list: D003692:Delayed-Action Preparations