A novel and innovative drug delivery system in fast dissolving oral film of glimepiride-betacyclodextrin inclusion complexes

Abstract

Delivery system in fast dissolving oral film is the system in which drug can be released immediately without drinking water and can be dissolved in saliva, then absorbed into the body through the oral cavity. Glimepiride is classified in the Biopharmaceutics Classification System class II which has a low solubility in water. Formation of glimepiride inclusion complexes using betacyclodextrin is known to increase solubility while suppressing the bitter taste of glimepiride. The purpose of this study was to develop FDOF preparations containing glimepiridebetacyclodextrin (1:2) inclusion complexes made by co-grinding technique. The development of the FDOF formula begins with the orientation of the formula which varies the concentration of crospovidone as superdisintegrant and PEG 400 as plasticizer. The FDOF were made from two formulas, with one formula containing glimepiride-betacyclodextrin (1:2) inclusion complexes and the other formula containing pure glimepiride as the active ingredient, using the solvent casting method with HPMC E5 LV as the film forming agent. The final evaluations of FDOF include organoleptic, weight variation, film thickness, surface pH, disintegration time, drug content, dissolution rate, percent elongation, tensile strength and folding endurance tests. The best FDOF formula from optimization process contain HPMC E5 LV 35% as film forming agent, PEG 400 15% as plasticizer and 8% crospovidone as superdisintegrant. From the results of final preparation evaluation, FDOF containing glimepiride-betacyclodextrin (1:2) inclusion complexes proved to be better than FDOF containing pure glimepiride.

Formulasi Dan Karakterisasi Sediaan Orally Dissolving Film Tamsulosin Hidroklorida

“…Uji keragaman bobot menggunakan alat timbangan analitik digital. Ditimbang 20 film yang diambil secara acak, merepresentasikan bagian samping dan tengah dari cetakan film (Darusman et al, 2020;Depkes RI, 2020).…”

“…Amati dan catat nilai pH pada saat elektroda pH meter menyentuh permukaan film. pH Sediaan ODF berkisar 7 atau mendekati 7 sesuai dengan pH rongga mulut (Joshua et al, 2016;Darusman et al, 2020).…”

“…Kadar tamsulosin HCl ditentukan menggunakan spektrofotometer UV˗Visible pada panjang gelombang serapan maksimumnya. Persyaratan kadar tamsulosin HCl dalam sediaan ODF berada pada rentang 98,5˗101% (Joshua et al, 2016;Darusman et al, 2020).…”