PMID- 33021427
OWN - NLM
STAT- MEDLINE
DCOM- 20210827
LR  - 20210827
IS  - 1097-9867 (Electronic)
IS  - 1083-7450 (Linking)
VI  - 26
IP  - 1
DP  - 2021 Jan
TI  - Effect of coating excipients on chemical stability of active coated tablets.
PG  - 41-47
LID - 10.1080/10837450.2020.1832520 [doi]
AB  - 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  degrees 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 Tablet samples were withdrawn and analyzed for degradants 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.
FAU - Kestur, Umesh
AU  - Kestur U
AD  - Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, 
      NJ, USA.
FAU - Desai, Divyakant
AU  - Desai D
AD  - Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, 
      NJ, USA.
FAU - Zong, Zhixin
AU  - Zong Z
AD  - Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, 
      NJ, USA.
FAU - Abraham, Anuji
AU  - Abraham A
AD  - Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, 
      NJ, USA.
FAU - Fiske, John
AU  - Fiske J
AD  - Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, 
      NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20201014
PL  - England
TA  - Pharm Dev Technol
JT  - Pharmaceutical development and technology
JID - 9610932
RN  - 0 (Excipients)
RN  - 0 (Tablets, Enteric-Coated)
SB  - IM
MH  - Chemistry, Pharmaceutical/*methods
MH  - Drug Stability
MH  - Excipients/analysis/*chemical synthesis
MH  - Magnetic Resonance Spectroscopy/methods
MH  - Solubility
MH  - Tablets, Enteric-Coated/analysis/*chemical synthesis
OTO - NOTNLM
OT  - Active film coating
OT  - chemical stability
OT  - excipients
OT  - plasticizer
OT  - polymer
EDAT- 2020/10/07 06:00
MHDA- 2021/08/28 06:00
CRDT- 2020/10/06 12:17
PHST- 2020/10/07 06:00 [pubmed]
PHST- 2021/08/28 06:00 [medline]
PHST- 2020/10/06 12:17 [entrez]
AID - 10.1080/10837450.2020.1832520 [doi]
PST - ppublish
SO  - Pharm Dev Technol. 2021 Jan;26(1):41-47. doi: 10.1080/10837450.2020.1832520. Epub 
      2020 Oct 14.