title: A protocol for assay of poly(lactide-co-glycolide) in clinical products.
abstract: Poly(lactide-co-glycolide) (PLGA) is the key component of long acting drug products responsible for providing sustained release in a controlled manner. The objective of the current study was to develop and validate an analytical protocol to determine key properties of PLGA used in commercial long-acting drug products. Procedures to isolate PLGA from commercial products have been established and the key properties of PLGA, such as polymer molecular weight, lactide:glycolide (L:G) ratio, and nature of polymer end-cap, have been determined. Identification of the polymer end-cap was confirmed by using two PLGA polymers with acid and ester end-caps. Trelstar(®) and Risperdal Consta(®) were chosen as model products. The calculated L:G ratios of PLGA used in Trelstar(®) and Risperdal(®) are 52:48 and 78:22, respectively. PLGAs from both Trelstar(®) and Risperdal Consta(®) possess ester end-caps. Since the properties of specific PLGA in clinically used formulations are not readily available, this protocol will be useful in developing PLGA-based long acting drug products.
authors: Akina, Inc., 3495 Kent Avenue, Suite O-100, West Lafayette, IN 47906, USA.
authors: John
authors: J
authors: Garner
authors: Akina, Inc., 3495 Kent Avenue, Suite O-100, West Lafayette, IN 47906, USA.
authors: Sarah
authors: S
authors: Skidmore
authors: Akina, Inc., 3495 Kent Avenue, Suite O-100, West Lafayette, IN 47906, USA.
authors: Haesun
authors: H
authors: Park
authors: Akina, Inc., 3495 Kent Avenue, Suite O-100, West Lafayette, IN 47906, USA. Electronic address: pk@akinainc.com.
authors: Kinam
authors: K
authors: Park
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors: Stephanie
authors: S
authors: Choi
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
authors: Yan
authors: Y
authors: Wang
mesh_terms: D003692:Delayed-Action Preparations / Q000032:analysis*; D004952:Esters / Q000032:analysis; D019344:Lactic Acid / Q000032:analysis*; D008863:Microspheres; D008970:Molecular Weight; D011100:Polyglycolic Acid / Q000032:analysis*; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D018967:Risperidone / Q000737:chemistry*; D017329:Triptorelin Pamoate / Q000737:chemistry*
chemical_list: D003692:Delayed-Action Preparations; D004952:Esters; D017329:Triptorelin Pamoate; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D018967:Risperidone
keywords: End-cap; Lactide:glycolide ratio; Molecular weight; PLGA; Risperidone; Triptorelin