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A top-down spectroscopic approach for correlating coating thickness distributions with the dissolution profiles of enterically coated pellets.
Xi, Wenjing; Yilmaz, Huzeyfe; Gao, Zongming; Rodriguez, Jason D; Willett, Daniel R.
Affiliation
  • Xi W; Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ)/Office of Testing and Research (OTR)/Division of Complex Drug Analysis (DCDA), 645 S. Newstead Ave., St. Louis, MO 63110, USA.
  • Yilmaz H; Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ)/Office of Testing and Research (OTR)/Division of Complex Drug Analysis (DCDA), 645 S. Newstead Ave., St. Louis, MO 63110, USA.
  • Gao Z; Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ)/Office of Testing and Research (OTR)/Division of Complex Drug Analysis (DCDA), 645 S. Newstead Ave., St. Louis, MO 63110, USA.
  • Rodriguez JD; Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ)/Office of Testing and Research (OTR)/Division of Complex Drug Analysis (DCDA), 645 S. Newstead Ave., St. Louis, MO 63110, USA.
  • Willett DR; Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER)/Office of Pharmaceutical Quality (OPQ)/Office of Testing and Research (OTR)/Division of Complex Drug Analysis (DCDA), 645 S. Newstead Ave., St. Louis, MO 63110, USA. Electronic address: daniel.willett@fda.hhs.gov.
J Pharm Biomed Anal ; 224: 115176, 2023 Feb 05.
Article in En | MEDLINE | ID: mdl-36423497
Pharmaceutical dosage forms such as tablets and capsules are often coated with a functional polymer to modify the drug release. To obtain the drug release profiles, ensure quality control and predict in-vivo performance, dissolution studies are performed. However, dissolution tests are time-consuming, sample destructive and do not readily allow for at-line or in-line characterization. Rapid assessment of functional coatings is essential for products where a single capsule is comprised of hundreds of functionally-coated pellets and the collective drug release kinetics of the entire capsule depends on contributions from each pellet. Here, single Raman measurements were used to evaluate the coating thickness distributions of a dosage form comprised of small, functionally-coated pellets in capsules. First, the composition and physicochemical properties of pellets were characterized by multivariate analysis assisted Raman mapping of pellet cross-sections. Second, a method of collecting single Raman spectrum with spectral contributions from the coating and API layers was developed and optimized to estimate the thickness of coatings. The coating thicknesses obtained from single Raman measurements of pellets in each capsule revealed thickness distributions that correlated with the dissolution profiles (capsules with one distribution had single stage release and capsules with two distributions had a two-stage release). Finally, an unsupervised multivariate analysis method was demonstrated as a rapid and efficient way to correlate dissolution profiles of enterically coated pellets. In summary, this study presents a non-destructive and rapid characterization method for assessing coating thickness and has the potential to be applied in process analytical technologies to ensure coating uniformity and predict product dissolution rate performance.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Polymers Language: En Journal: J Pharm Biomed Anal Year: 2023 Document type: Article Affiliation country: United States Country of publication: United kingdom

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Polymers Language: En Journal: J Pharm Biomed Anal Year: 2023 Document type: Article Affiliation country: United States Country of publication: United kingdom