The manufacture of low-dose oral solid dosage form to support early clinical studies using an automated micro-filing system

Mingda Bi, Changquan Calvin Sun, Francisco Alvarez, Fernando Alvarez-Nunez

Research output: Contribution to journalArticle

15 Scopus citations

Abstract

Automated powder dispensing systems enable supplying early clinical studies using drug-in-capsule approach, which is material sparing and requires a minimum amount of resources. However, the inability of accurately filling the capsule with a small amount, e.g., several micrograms, of drug limits the use of these systems for potent drugs. We demonstrate that formulated powder blends can be used to successfully fill capsules containing 5 μg to 5 mg of drug with adequate content uniformity. Effective formulation and process strategies that enable this approach are presented with examples.

Original languageEnglish (US)
Pages (from-to)88-95
Number of pages8
JournalAAPS PharmSciTech
Volume12
Issue number1
DOIs
StatePublished - Mar 1 2011

Keywords

  • automated powder dispensing system
  • early clinical studies
  • low-dose oral solid

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