Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC.

Sankalia, JM ; Sankalia, MG ; et al.

In: Journal of controlled release : official journal of the Controlled Release Society, Jg. 129 (2008-07-02), Heft 1, S. 49-58

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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.

Titel:	Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC.
Autor/in / Beteiligte Person:	Sankalia, JM ; Sankalia, MG ; Mashru, RC
Zeitschrift:	Journal of controlled release : official journal of the Controlled Release Society, Jg. 129 (2008-07-02), Heft 1, S. 49-58
Veröffentlichung:	Amsterdam : Elsevier Science Publishers, 1984-, 2008
Medientyp:	academicJournal
ISSN:	1873-4995 (electronic)
DOI:	10.1016/j.jconrel.2008.03.016
Schlagwort:	Administration, Oral Animals Cellulose analogs & derivatives Cellulose chemistry Chemistry, Pharmaceutical Delayed-Action Preparations Diffusion Drug Compounding Drug Stability Galactans chemistry Glipizide administration & dosage Hypoglycemic Agents administration & dosage Hypromellose Derivatives Kinetics Lactose chemistry Mannans chemistry Methylcellulose analogs & derivatives Methylcellulose chemistry Microscopy, Electron, Scanning Models, Biological Models, Chemical Plant Gums chemistry Rabbits Reproducibility of Results Solubility Starch chemistry Tablets Technology, Pharmaceutical methods Drug Carriers Excipients chemistry Glipizide chemistry Glipizide pharmacokinetics Hypoglycemic Agents chemistry Hypoglycemic Agents pharmacokinetics Polysaccharides, Bacterial chemistry Water chemistry
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article Language: English [J Control Release] 2008 Jul 02; Vol. 129 (1), pp. 49-58. <i>Date of Electronic Publication: </i>2008 Mar 26. MeSH Terms: Drug Carriers* ; Excipients / chemistry ; Glipizide / chemistry ; Glipizide / pharmacokinetics ; Hypoglycemic Agents / chemistry ; Hypoglycemic Agents / pharmacokinetics ; Polysaccharides, Bacterial / chemistry ; Water / *chemistry ; Administration, Oral ; Animals ; Cellulose / analogs & derivatives ; Cellulose / chemistry ; Chemistry, Pharmaceutical ; Delayed-Action Preparations ; Diffusion ; Drug Compounding ; Drug Stability ; Galactans / chemistry ; Glipizide / administration & dosage ; Hypoglycemic Agents / administration & dosage ; Hypromellose Derivatives ; Kinetics ; Lactose / chemistry ; Mannans / chemistry ; Methylcellulose / analogs & derivatives ; Methylcellulose / chemistry ; Microscopy, Electron, Scanning ; Models, Biological ; Models, Chemical ; Plant Gums / chemistry ; Rabbits ; Reproducibility of Results ; Solubility ; Starch / chemistry ; Tablets ; Technology, Pharmaceutical / methods Substance Nomenclature: 0 (Delayed-Action Preparations) ; 0 (Drug Carriers) ; 0 (Excipients) ; 0 (Galactans) ; 0 (Hypoglycemic Agents) ; 0 (Mannans) ; 0 (Plant Gums) ; 0 (Polysaccharides, Bacterial) ; 0 (Tablets) ; 059QF0KO0R (Water) ; 3NXW29V3WO (Hypromellose Derivatives) ; 7Z8S9VYZ4B (ethyl cellulose) ; 9004-34-6 (Cellulose) ; 9004-67-5 (Methylcellulose) ; 9005-25-8 (Starch) ; E89I1637KE (guar gum) ; J2B2A4N98G (Lactose) ; OP1R32D61U (microcrystalline cellulose) ; TTV12P4NEE (xanthan gum) ; X7WDT95N5C (Glipizide) Entry Date(s): Date Created: 20080506 Date Completed: 20080813 Latest Revision: 20161124 Update Code: 20240513

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