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  • In vitro and in vivo evaluation of novel osmotic pump tablets of isosorbide-5-mononitrate containing polyvinyl pyrrolidone (PVP) for controlled release.

In vitro and in vivo evaluation of novel osmotic pump tablets of isosorbide-5-mononitrate containing polyvinyl pyrrolidone (PVP) for controlled release.

Die Pharmazie (2012-09-11)
Xin Li, Qingwei Jiang, Lina Du, Chenyun Wang, Qiang Chi
ABSTRACT

A novel osmotic pump tablet with ethyl cellulose (EC) and polyvinyl pyrrolidone (PVP) as the semipermeable membrane and isosorbide-5-mononitrate (5-ISMN) as the model drug was formulated in this study. Zero order release kinetics were attained by avoiding aging during storage. Drug release increased with an increase in the percentage of PVP K30 in the semipermeable membrane. However, drug release decreased with increased coating weight. Drug release rates decreased continuously for tablets coated with EC/PEG4000 and cellulose acetate (CA)/PEG4000. This tendency was more marked with longer storage time. However, there was little change in drug release rates for tablets with a semipermeable membrane of EC/PVP K30 at 6, 12 or 24 months. The weight loss test also validated the results mentioned above. The relative bioavailability of the osmotic-pump tablets against the reference formulation in single and multiple dose regimens was 116.7 and 106.5, respectively. This means that the bioavailability of osmotic pump tablets using PVP as the plasticiser was equal to that of the reference formulation. In general, 5-ISMN osmotic pump tablets with a semipermeable membrane composed of EC/PVP K30 may be useful in providing constant drug delivery with minimum fluctuations during longer storage time.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Ethyl cellulose, viscosity 46 cP, 5 % in toluene/ethanol 80:20(lit.), extent of labeling: 48% ethoxyl
Sigma-Aldrich
Ethyl cellulose, viscosity 10 cP, 5 % in toluene/ethanol 80:20(lit.), extent of labeling: 48% ethoxyl
Sigma-Aldrich
Ethyl cellulose, viscosity 22 cP, 5 % in toluene/ethanol 80:20(lit.), extent of labeling: 48% ethoxyl
Sigma-Aldrich
Ethyl cellulose, viscosity 300 cP, 5 % in toluene/ethanol 80:20(lit.), extent of labeling: 48% ethoxyl
Sigma-Aldrich
Ethyl cellulose, viscosity 100 cP, 5 % in toluene/ethanol 80:20(lit.), extent of labeling: 48% ethoxyl
Sigma-Aldrich
Ethyl cellulose, 48.0-49.5% (w/w) ethoxyl basis
Sigma-Aldrich
Ethyl cellulose, viscosity 4 cP, 5 % in toluene/ethanol 80:20(lit.), extent of labeling: 48% ethoxyl
Sigma-Aldrich
Ethyl cellulose, CP, viscosity 45 cP 
Sigma-Aldrich
Ethyl cellulose, 48.0-49.5% (w/w) ethoxyl basis