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Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC.
J Control Release. 2008 Jul 02; 129(1):49-58.JC

Abstract

The purpose of this study was to examine a level A in vitro-in vivo correlation (IVIVC) for glipizide hydrophilic sustained-release matrices, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. The effect of polymeric blends of ethylcellulose, microcrystalline cellulose, hydroxypropylmethylcellulose, xanthan gum, guar gum, Starch 1500, and lactose on in vitro release profiles was studied and fitted to various release kinetics models. Water uptake kinetics with scanning electron microscopy (SEM) was carried out to support the drug release mechanism. An IVIVC was established by comparing the pharmacokinetic parameters of optimized (M-24) and marketed (Glytop-2.5 SR) formulations after single oral dose studies on white albino rabbits. The matrix M-19 (xanthan:MCC PH301 at 70:40) and M-24 (xanthan:HPMC K4M:Starch 1500 at 70:25:15) showed the glipizide release within the predetermined constraints at all time points with Korsmeyer-Peppas' and zero-order release mechanism, respectively. Kopcha model revealed that the xanthan gum is the major excipient responsible for the diffusional release profile and was further supported by SEM and swelling studies. A significant level A IVIVC with acceptable limits of prediction errors (below 15%) enables the prediction of in vivo performance from their in vitro release profile. It was concluded that proper selection of rate-controlling polymers with release rate modifier excipients will determine overall release profile, duration and mechanism from directly compressed matrices.

Authors+Show Affiliations

Centre of Relevance and Excellence in Novel Drug Delivery Systems, Pharmacy Department, The M. S. University of Baroda, G. H. Patel Building, Donor's Plaza, Vadodara, Gujarat 390002, India. jollymayur@hotmail.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18456362

Citation

Sankalia, Jolly M., et al. "Drug Release and Swelling Kinetics of Directly Compressed Glipizide Sustained-release Matrices: Establishment of Level a IVIVC." Journal of Controlled Release : Official Journal of the Controlled Release Society, vol. 129, no. 1, 2008, pp. 49-58.
Sankalia JM, Sankalia MG, Mashru RC. Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC. J Control Release. 2008;129(1):49-58.
Sankalia, J. M., Sankalia, M. G., & Mashru, R. C. (2008). Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC. Journal of Controlled Release : Official Journal of the Controlled Release Society, 129(1), 49-58. https://doi.org/10.1016/j.jconrel.2008.03.016
Sankalia JM, Sankalia MG, Mashru RC. Drug Release and Swelling Kinetics of Directly Compressed Glipizide Sustained-release Matrices: Establishment of Level a IVIVC. J Control Release. 2008 Jul 2;129(1):49-58. PubMed PMID: 18456362.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC. AU - Sankalia,Jolly M, AU - Sankalia,Mayur G, AU - Mashru,Rajashree C, Y1 - 2008/03/26/ PY - 2008/01/06/received PY - 2008/02/24/revised PY - 2008/03/16/accepted PY - 2008/5/6/pubmed PY - 2008/8/14/medline PY - 2008/5/6/entrez SP - 49 EP - 58 JF - Journal of controlled release : official journal of the Controlled Release Society JO - J Control Release VL - 129 IS - 1 N2 - The purpose of this study was to examine a level A in vitro-in vivo correlation (IVIVC) for glipizide hydrophilic sustained-release matrices, with an acceptable internal predictability, in the presence of a range of formulation/manufacturing changes. The effect of polymeric blends of ethylcellulose, microcrystalline cellulose, hydroxypropylmethylcellulose, xanthan gum, guar gum, Starch 1500, and lactose on in vitro release profiles was studied and fitted to various release kinetics models. Water uptake kinetics with scanning electron microscopy (SEM) was carried out to support the drug release mechanism. An IVIVC was established by comparing the pharmacokinetic parameters of optimized (M-24) and marketed (Glytop-2.5 SR) formulations after single oral dose studies on white albino rabbits. The matrix M-19 (xanthan:MCC PH301 at 70:40) and M-24 (xanthan:HPMC K4M:Starch 1500 at 70:25:15) showed the glipizide release within the predetermined constraints at all time points with Korsmeyer-Peppas' and zero-order release mechanism, respectively. Kopcha model revealed that the xanthan gum is the major excipient responsible for the diffusional release profile and was further supported by SEM and swelling studies. A significant level A IVIVC with acceptable limits of prediction errors (below 15%) enables the prediction of in vivo performance from their in vitro release profile. It was concluded that proper selection of rate-controlling polymers with release rate modifier excipients will determine overall release profile, duration and mechanism from directly compressed matrices. SN - 1873-4995 UR - https://www.unboundmedicine.com/medline/citation/18456362/Drug_release_and_swelling_kinetics_of_directly_compressed_glipizide_sustained_release_matrices:_establishment_of_level_A_IVIVC_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-3659(08)00159-4 DB - PRIME DP - Unbound Medicine ER -