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  • The influence of process variables of preparation of oxycellulose beads on their dissolution profile.

The influence of process variables of preparation of oxycellulose beads on their dissolution profile.

Acta poloniae pharmaceutica (2013-04-26)
Martina Bajerová, Jan Muselík, Jan Gajdziok, Ruta Masteiková, Katerina Dvorácková
ABSTRACT

Particles preparation from biodegradable polymers as carriers for the controlled release of drugs has been the focus of many investigations and the subject of a growing field of research in recent years. The aim of this study was to develop and optimize the preparation of oxycellulose beads containing diclofenac sodium as a model drug. Particle size, surface, drug content and encapsulation efficiency were evaluated, drug dissolution profiles were measured and drug release mechanism estimated. The prepared oxycellulose beads were uniform in size with encapsulation efficiency ranging from 53.2 to 74.9%. The lower temperature of the crosslinking solution and its saturation with diclofenac sodium increased the encapsulation efficiency, especially when both parameters were combined. The application of ultrasound had a negative effect on drug encapsulation. The dissolution of diclofenac sodium in pH 1.2 was close to zero as its solubility in this medium is very limited. The drug release in pH 6.8 lasted from 10 to 16 h showing biphasic behavior with a significant lag time. T1/2 decreased with increasing encapsulation efficiency and ultrasound application. Diclofenac sodium was released from the prepared oxycellulose particles by diffusion as well as by erosion process; ahigh correlation was found with zero order kinetics.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Methyl cellulose, viscosity 3000-5500 mPa.s, 2 % in H2O(20 °C)
Sigma-Aldrich
Methyl cellulose, medium viscosity, Methoxyl content 27.5-31.5 %
Sigma-Aldrich
Methyl cellulose, 27.5-31.5% methoxyl basis
Sigma-Aldrich
Methyl cellulose, tested according to Ph. Eur.
Supelco
Calcium standard for AAS, analytical standard, 1.000 g/L Ca+2 in hydrochloric acid, traceable to BAM
Supelco
Diclofenac sodium salt, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
(Hydroxypropyl)methyl cellulose
Sigma-Aldrich
Calcium chloride dihydrate, BioUltra, for molecular biology, ≥99.5% (KT)
Sigma-Aldrich
(Hydroxypropyl)methyl cellulose, average Mn ~10,000
Sigma-Aldrich
(Hydroxypropyl)methyl cellulose, average Mn ~90,000
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(Hydroxypropyl)methyl cellulose, average Mn ~120,000
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(Hydroxypropyl)methyl cellulose, average Mn ~86,000
Sigma-Aldrich
Calcium chloride dihydrate, tested according to Ph. Eur.
Sigma-Aldrich
(Hydroxypropyl)methyl cellulose, viscosity 40-60 cP, 2 % in H2O(20 °C)(lit.)
Sigma-Aldrich
Methyl cellulose, 26.0-33.0% (Methoxy group (dry basis)), meets USP testing specifications, viscosity: 1,500 cP
Sigma-Aldrich
Methyl cellulose, 27.5-31.5% (Methoxyl content), viscosity: 400 cP
Sigma-Aldrich
Methyl cellulose, viscosity: 25 cP
Sigma-Aldrich
Methyl cellulose, viscosity: 4,000 cP
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Hypromellose, meets USP testing specifications
Sigma-Aldrich
(Hydroxypropyl)methyl cellulose, viscosity 80-120 cP, 2 % in H2O(20 °C)(lit.)
Sigma-Aldrich
(Hydroxypropyl)methyl cellulose, viscosity 2,600-5,600 cP, 2 % in H2O(20 °C)(lit.)
Sigma-Aldrich
Calcium chloride dihydrate, for molecular biology, ≥99.0%
Sigma-Aldrich
Calcium chloride dihydrate, BioXtra, ≥99.0%
Sigma-Aldrich
Methyl cellulose, viscosity: 15 cP, BioReagent, suitable for cell culture
Sigma-Aldrich
Methyl cellulose, meets USP testing specifications, 26.0-33.0% (methoxyl group, on Dry Basis), viscosity: 400 cP
Sigma-Aldrich
Methyl cellulose, viscosity: 15 cP
Sigma-Aldrich
Diclofenac sodium salt
Sigma-Aldrich
Methyl cellulose, viscosity: 1,500 cP
Sigma-Aldrich
Calcium chloride dihydrate, BioReagent, suitable for cell culture, suitable for insect cell culture, suitable for plant cell culture, ≥99.0%
Diclofenac potassium, European Pharmacopoeia (EP) Reference Standard