Influence of temperature and shaking on stability of insulin preparations: Degradation kinetics

Oliva, Alexis; Fariña, José B.; Llabrés, Matı́as

doi:10.1016/s0378-5173(96)04700-x

Cited by 54 publications

(41 citation statements)

References 14 publications

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“…The RP-HPLC consisted of the C-18 column; the mobile phase was 0.2 M sodium sulphate (pH 2.3) and acetonitrile in the ratio of 74:26. The flow rate was 1 ml/min and the insulin was detected using UV detector at 214 nm [10].…”

Section: Methodsmentioning

confidence: 99%

Formulation and Evaluation of a Chitosan-Pva-Gellan Insulin Implant

Satish

2017

Int J App Pharm

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Objective: The purpose of this study was to ascertain the applicability of degradable materials for fabrication of an insulin release system. Methods:Insulin implants were prepared by using poly (vinyl alcohol) (PVA), gellan and chitosan by solution casting method. The prepared implants were evaluated for swellability, content uniformity, potency and purity of insulin in implants, scanning electron microscopy studies, in vitro release studies, in vitro degradation studies using lysozyme, stability studies and circular dichroism spectroscopy. Results:The swelling degree of the implants was found to be in the range of 1.07-1.56. The diffusion coefficient of water through the implant was found to depend on the calcium chloride (CaCl2) concentration. The diffusion coefficient of insulin through the chitosan-PVA-gellan in the early stages was found to be in the range of 1.99×10 -5 cm 2 /sec to 5.24×10 -5 cm 2 /sec and at later stages in the range of 6.9×10 -6 cm 2 /sec to 1.10×10 -5 cm 2 /sec. The weight of the implants was 48±0.58 mg. The insulin content in the implants was 9.86±0.10 mg. The potency of insulin extracted from the implants was 27.11±0.75 U/mg or 95.12±2.61 % of the control insulin. The in vitro release studies showed that insulin was released completely in a period of 13-19 d depending on the composition of the implant. The increase in CaCl2Conclusion: These studies provide validity for the potential utility of chitosan-PVA-gellan implant systems for the delivery of insulin. The studies also demonstrate that insulin maintained its integrity within the implant system. Implants showed the complete release of insulin in 19 d and the release of insulin from the implants depended on the amount of CaCl retarded the rate of insulin release whereas the increase in PVA content leads to the rapid release of insulin. The device was found to undergo significant weight loss due to enzyme mediated degradation.

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Section: Methodsmentioning

confidence: 99%

Formulation and Evaluation of a Chitosan-Pva-Gellan Insulin Implant

Satish

2017

Int J App Pharm

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“…33 Many factors such as temperature and agitation could have contributed to reduction in the released insulin stability. 34 The reduction in released insulin conformational stability could be attributed to insulin prolonged existence in agitated media at 37 • C temperature. 34 We do not expect this to happen in the In Vivo studies as released insulin will be rapidly absorbed.…”

Section: Stability Studiesmentioning

confidence: 99%

“…34 The reduction in released insulin conformational stability could be attributed to insulin prolonged existence in agitated media at 37 • C temperature. 34 We do not expect this to happen in the In Vivo studies as released insulin will be rapidly absorbed. Yet, conservation of most of denaturation peak in DSC thermogram and CD characteristic spectrum demonstrate that the conformational stability and secondary structure were greatly preserved during the delivery systems preparation and release.…”

Section: Stability Studiesmentioning

confidence: 99%

Controlled Delivery of Basal Insulin from Phase-Sensitive Polymeric Systems After Subcutaneous Administration: In Vitro Release, Stability, Biocompatibility, In Vivo Absorption, and Bioactivity of Insulin

Al-Tahami

Oak

Singh

2011

Journal of Pharmaceutical Sciences

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“…The rate constant of the reaction (k) was calculated according to a determined order at each of the three temperatures. The logarithmic K values at different temperatures were plotted against the reciprocal of the corresponding temperature according to Arrhenius plot for the determination of the expiration date (26)(27)(28).…”

Section: Accelerated Stability Testingmentioning

confidence: 99%

Floating Tablet of Trimetazidine Dihydrochloride: An Approach for Extended Release with Zero-Order Kinetics

et al. 2010

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Abstract. Trimetazidine dihydrochloride is an effective anti-anginal agent; however, it is freely soluble in water and suffers from a relatively short half-life. To solve this encumbrance, it is a prospective candidate for fabricating trimetazidine extended-release formulations. Trimetazidine extended-release floating tablets were prepared using different hydrophilic matrix forming polymers including HPMC 4000 cps, carbopol 971P, polycarbophil, and guar gum. The tablets were fabricated by dry coating technique. In vitro evaluation of the prepared tablets was performed by the determination of the hardness, friability, content uniformity, and weight variation. The floating lag time and floating duration were also evaluated. Release profile of the prepared tablets was performed and analyzed. Furthermore, a stability study of the floating tablets was carried out at three different temperatures over 12 weeks. Finally, in vivo bioavailability study was done on human volunteers. All tablet formulas achieved <0.5 min of floating lag time, more than 12 h of floating duration, and extended t 1/2 . The drug release in all formulas followed zero-order kinetics. T4 and T8 tablets contained the least polymer concentration and complied with the dissolution requirements for controlled-release dosage forms. These two formulas were selected for further stability studies. T8 exhibited longer expiration date and was chosen for in vivo studies. T8 floating tablets showed an improvement in the drug bioavailability compared to immediate-release tablets (Vastrel® 20 mg).

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Influence of temperature and shaking on stability of insulin preparations: Degradation kinetics

Cited by 54 publications

References 14 publications

Formulation and Evaluation of a Chitosan-Pva-Gellan Insulin Implant

Formulation and Evaluation of a Chitosan-Pva-Gellan Insulin Implant

Controlled Delivery of Basal Insulin from Phase-Sensitive Polymeric Systems After Subcutaneous Administration: In Vitro Release, Stability, Biocompatibility, In Vivo Absorption, and Bioactivity of Insulin

Floating Tablet of Trimetazidine Dihydrochloride: An Approach for Extended Release with Zero-Order Kinetics

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