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Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique.
Drug Dev Ind Pharm. 2004 May; 30(5):525-34.DD

Abstract

Glyburide is a poorly water-soluble oral hypoglycemic agent, with problems of variable bioavailability and bio-inequivalence related to its poor water-solubility. This work investigated the possibility of developing glyburide tablets, allowing fast, reproducible, and complete drug dissolution, by using drug solid dispersion in polyethylene glycol. Phase-solubility studies were performed to investigate the drug-carrier interactions in solution, whereas differential scanning calorimetry, X-ray powder diffraction, and infrared spectroscopy were used to characterize the solid state of solid dispersions. The effects of several variables related to both solid dispersion preparation (cofusion or coevaporation technique, drug-to-carrier ratio, polyethylene glycol molecular weight) and tablet production (direct compression or previous wet-granulation, tablet hardness, drug, and solid dispersion particle size) on drug dissolution behavior were investigated. Tablets obtained by direct compression, with a hardness of 7-9 Kp, and containing larger sized solid dispersions (20-35 mesh, i.e., 850-500 microm) of micronized glyburide in polyethylene glycol 6000 prepared by the cofusion method gave the best results, with a 135% increase in drug dissolution efficiency at 60 min in comparison with a reference tablet formulation containing the pure micronized drug. Moreover, the glyburide dissolution profile from the newly developed tablets was clearly better than those from various commercial tablets at the same drug dosage.

Authors+Show Affiliations

Menarini Manufacturing Logistics and Services, Firenze, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15244088

Citation

Valleri, M, et al. "Development and Evaluation of Glyburide Fast Dissolving Tablets Using Solid Dispersion Technique." Drug Development and Industrial Pharmacy, vol. 30, no. 5, 2004, pp. 525-34.
Valleri M, Mura P, Maestrelli F, et al. Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique. Drug Dev Ind Pharm. 2004;30(5):525-34.
Valleri, M., Mura, P., Maestrelli, F., Cirri, M., & Ballerini, R. (2004). Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique. Drug Development and Industrial Pharmacy, 30(5), 525-34.
Valleri M, et al. Development and Evaluation of Glyburide Fast Dissolving Tablets Using Solid Dispersion Technique. Drug Dev Ind Pharm. 2004;30(5):525-34. PubMed PMID: 15244088.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and evaluation of glyburide fast dissolving tablets using solid dispersion technique. AU - Valleri,M, AU - Mura,P, AU - Maestrelli,F, AU - Cirri,M, AU - Ballerini,R, PY - 2004/7/13/pubmed PY - 2004/9/15/medline PY - 2004/7/13/entrez SP - 525 EP - 34 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 30 IS - 5 N2 - Glyburide is a poorly water-soluble oral hypoglycemic agent, with problems of variable bioavailability and bio-inequivalence related to its poor water-solubility. This work investigated the possibility of developing glyburide tablets, allowing fast, reproducible, and complete drug dissolution, by using drug solid dispersion in polyethylene glycol. Phase-solubility studies were performed to investigate the drug-carrier interactions in solution, whereas differential scanning calorimetry, X-ray powder diffraction, and infrared spectroscopy were used to characterize the solid state of solid dispersions. The effects of several variables related to both solid dispersion preparation (cofusion or coevaporation technique, drug-to-carrier ratio, polyethylene glycol molecular weight) and tablet production (direct compression or previous wet-granulation, tablet hardness, drug, and solid dispersion particle size) on drug dissolution behavior were investigated. Tablets obtained by direct compression, with a hardness of 7-9 Kp, and containing larger sized solid dispersions (20-35 mesh, i.e., 850-500 microm) of micronized glyburide in polyethylene glycol 6000 prepared by the cofusion method gave the best results, with a 135% increase in drug dissolution efficiency at 60 min in comparison with a reference tablet formulation containing the pure micronized drug. Moreover, the glyburide dissolution profile from the newly developed tablets was clearly better than those from various commercial tablets at the same drug dosage. SN - 0363-9045 UR - https://www.unboundmedicine.com/medline/citation/15244088/Development_and_evaluation_of_glyburide_fast_dissolving_tablets_using_solid_dispersion_technique_ L2 - https://www.tandfonline.com/doi/full/10.1081/ddc-120037483 DB - PRIME DP - Unbound Medicine ER -