Perez M A, Ghaly E S, Marti A
School of Pharmacy, University of Puerto Rico, San Juan 00936-5067.
P R Health Sci J. 1993 Dec;12(4):263-7.
Sustained release phenylpropanolamine HCl tablets were prepared with compritol as a retardant material. The effects of varying wax levels and methods of matrix formation on drug release were investigated. Also the compaction profiles were recorded for all formulations. The amount of drug in the formula was held constant (10% w/w), while the wax level was varied from 10% to 50% w/w. Two methods were used for the preparation of drug: wax systems; physical mixture and solid dispersion. The drug release from tablets containing 10% Compritol and prepared by solid dispersion was 97% after six hours of testing dissolution. Tablets prepared with 30% wax released 72% of the drug, while tablets containing 50% wax released only 30% of the drug after six hours. Tablets prepared by physical mixture gave higher drug release than tablets prepared by solid dispersion method. The incorporation of Compritol decreased the ejection forces of tablets during compaction. The drug release from tablets prepared by solid dispersion followed the diffusion controlled model described by Higuchi for inert porous matrix.
以康普立多作为阻滞剂制备盐酸苯丙醇胺缓释片。研究了不同蜡含量和基质形成方法对药物释放的影响。还记录了所有制剂的压片曲线。配方中药物的量保持恒定(10% w/w),而蜡含量从10%到50% w/w不等。制备药物-蜡体系有两种方法:物理混合物法和固体分散体法。通过固体分散体制备的含10%康普立多的片剂在测试溶出6小时后药物释放率为97%。含30%蜡制备的片剂在6小时后释放72%的药物,而含50%蜡的片剂在6小时后仅释放30%的药物。通过物理混合物法制备的片剂比通过固体分散体法制备的片剂药物释放率更高。加入康普立多降低了压片过程中片剂的推出力。通过固体分散体制备的片剂的药物释放遵循Higuchi描述的惰性多孔基质的扩散控制模型。