title: The manufacture of low-dose oral solid dosage form to support early clinical studies using an automated micro-filing system.
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.
authors.affiliation: Formulation development group, Pharmaceutical R&D, Amgen Inc, Thousand Oaks, California, USA. mbi@amgen.com
authors.forename: Mingda
authors.initials: M
authors.lastname: Bi
authors.forename: Changquan Calvin
authors.initials: CC
authors.lastname: Sun
authors.forename: Francisco
authors.initials: F
authors.lastname: Alvarez
authors.forename: Fernando
authors.initials: F
authors.lastname: Alvarez-Nunez
mesh_terms: D000284:Administration, Oral; D002214:Capsules; D017321:Clinical Trials, Phase I as Topic; D004304:Dosage Forms; D004339:Drug Compounding / Q000379:methods*; D005079:Excipients; D006801:Humans; D007785:Lactose; D008420:Manufactured Materials; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry*; D011208:Powders
chemical_list: D002214:Capsules; D004304:Dosage Forms; D005079:Excipients; D004364:Pharmaceutical Preparations; D011208:Powders; D007785:Lactose