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Tytuł:
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Effect of coating excipients on chemical stability of active coated tablets.
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Autorzy:
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Kestur U; Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, NJ, USA.
Desai D; Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, NJ, USA.
Zong Z; Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, NJ, USA.
Abraham A; Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, NJ, USA.
Fiske J; Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, NJ, USA.
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Źródło:
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Pharmaceutical development and technology [Pharm Dev Technol] 2021 Jan; Vol. 26 (1), pp. 41-47. Date of Electronic Publication: 2020 Oct 14.
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Publication: London : Informa Healthcare
Original Publication: Monticello, NY : Marcel Dekker, c1996-
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MeSH Terms:
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Chemistry, Pharmaceutical/*methods
Excipients/*chemical synthesis
Tablets, Enteric-Coated/*chemical synthesis
Drug Stability ; Excipients/analysis ; Magnetic Resonance Spectroscopy/methods ; Solubility ; Tablets, Enteric-Coated/analysis
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Contributed Indexing:
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Keywords: Active film coating; chemical stability; excipients; plasticizer; polymer
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Substance Nomenclature:
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0 (Excipients)
0 (Tablets, Enteric-Coated)
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Entry Date(s):
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Date Created: 20201006 Date Completed: 20210827 Latest Revision: 20210827
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Update Code:
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20240105
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DOI:
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10.1080/10837450.2020.1832520
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PMID:
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33021427
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The objective of this study was to understand the impact of coating excipients on the chemical stability of active pan coated peliglitazar, which was prone to acid as well as base-catalyzed degradation. Four different coating formulations containing either polyvinyl alcohol (PVA) or hydroxypropyl methylcellulose (HPMC) as a coating polymer and triacetin (glycerol triacetate) or polyethylene glycol (PEG) as a plasticizer/detackifier were used for coating of peliglitazar in a perforated pan coater. Tablets of one-milligram strength were manufactured by suspending the drug in the coating suspension and spray coating onto inert core tablets. The active coated tablets were placed on stability (40 °C/75% RH) in high-density polyethylene (HDPE) bottles in closed condition with desiccants or in open condition. Tablet samples were withdrawn and analyzed for degradants using a stability-indicating HPLC method. The overall stability for the film-forming polymer-plasticizer/detackifier combination showed the rank order: HPMC-triacetin > PVA-triacetin > HPMC-PEG > PVA-PEG. Higher stability of triacetin systems over PEG systems was attributed to lower solubility of peliglitazar in triacetin coating systems. For the same plasticizer/detackifier, higher stability of HPMC over PVA-based formulations was attributed to lower solubility and mobility of peliglitazar in HPMC compared with the PVA-based coating.
