Linka Wojciech, Kot Mateusz, Kołodziejczyk Michał
Zakład Technologii Postaci Leku, Uniwersytet Medyczny w Łodzi, Łódź, Polska.
Polim Med. 2016 Jul-Dec;46(2):145-153. doi: 10.17219/pim/69296.
One of the most important challenges of the modern technology of solid oral dosage forms is to increase the effectiveness of the drug, reduce side effects and improve the comfort of use. One way to obtain such effects are prolonged release dosage forms.
The aim of the study was to investigate the suitability of polymers (synthetic - Kollidon K30 and semisynthetic - hydroxypropyl methylcellulose), and calcium hydrogen phosphate dihydrate - as an inorganic insoluble filler - in the construction of the matrices of the solid oral dosage forms containing non-steroidal anti-inflammatory drugs (NSAIDs). We used ketoprofen as a model active ingredient.
Ketoprofenum, hydroxypropylmethylcellulose, calcium hydrogen phosphate, kollidon K30, magnesium stearate. Incorporation. Studies of the tablet mass. Direct tabletting. Studies of the pharmacopoeial parameters and pharmaceutical availability. Measurements of the viscosity of 1% solution of HPMC and Kollidon K30. Approximation of the results.
We obtained three versions (formulations) of the matrices. The results of the granulometric research on tablet formulations were consistent with the standards. The results of morphological studies and pharmacopoeial tablets were consistent with the standards. The best results were obtained for the release formulations containing HPMC and calcium hydrogenphoshate. Kollidon K30 accelerated the release of ketoprofen from tablets of formulation I.
The model system of preformulation studies showed the usefulness of HPMC and Kollidon K30 in the technology of hydrophilic matrices with ketoprofen.
固体口服剂型现代技术面临的最重要挑战之一是提高药物疗效、减少副作用并提高使用舒适度。实现这些效果的一种方法是采用缓释剂型。
本研究旨在探讨聚合物（合成聚合物——聚维酮K30和半合成聚合物——羟丙基甲基纤维素）以及磷酸氢钙二水合物（作为无机不溶性填充剂）在构建含非甾体抗炎药（NSAIDs）的固体口服剂型基质中的适用性。我们使用酮洛芬作为模型活性成分。
酮洛芬、羟丙基甲基纤维素、磷酸氢钙、聚维酮K30、硬脂酸镁。混合。片剂质量研究。直接压片。药典参数和药物可及性研究。1%羟丙基甲基纤维素和聚维酮K30溶液粘度的测量。结果近似。
我们获得了三种基质版本（配方）。片剂配方的粒度研究结果符合标准。形态学研究和药典片剂的结果符合标准。含羟丙基甲基纤维素和磷酸氢钙的释放配方取得了最佳结果。聚维酮K30加速了酮洛芬从配方I片剂中的释放。
预制剂研究的模型系统表明，羟丙基甲基纤维素和聚维酮K30在含酮洛芬的亲水性基质技术中有用。
