Formulation and Evaluation of Fixed-Dose Combination Immediate Release Tablets of Ibuprofen and Famotidine through Quality by Design Approach

Bangladesh Pharmaceutical Journal Pub Date : 2021-07-10 DOI:10.3329/BPJ.V24I2.54712

M. Alam, Shahidul Islam, K. Sikdar, Asm Monjur Al Hossain

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Abstract

Nonsteroidal anti-inflammatory drugs (NSAIDs) are frequently prescribed by the physicians for the management of pain due to their anti-inflammatory and analgesic properties. Long term use of NSAIDs causes gastrointestinal (GI) toxicity and the common GI disorders are indigestion, ulcers or bleeding. Therefore, the production of local oral tablets containing NSAIDs and gastro-protectant is inevitable. In this experiment, combination of ibuprofen 600 mg and famotidine 20 mg tablets were prepared by direct compression technique, which is unique in Bangladesh. To pursue the study Design of Experiments (DoE) approach was implemented to create fifteen trial formulations where Polyvinylpyrrolidone (PVPK30) 1%-3%, Microcrystalline Cellulose (Avicel PH-102) 1%-7% and Starch-1500 1%-13% were considered as independent variables and the responses were depicted in friability and disintegration time which were found 0.21–0.45% and 1.8–20.5 minutes respectively. Out of fifteen formulation trials (F-1 to F-15), seven formulations (F-3, F-6, F-8, F-9, F-10, F-13 and F-14) had met the acceptable criteria and one formulation (F-9) with independent variables PVP-K30 2.00%, Avicel PH-102 4.75% and Starch-1500 6.5% was selected because of its better disintegration, dissolution and friability profile. Data obtained from in-vitro dissolution tests were fitted to different kinetic models such as zero order, first order, Higuchi, Hixson-Crowell and Korsmeyer-Peppas models. Also, a compatibility study was conducted using Fourier Transform Infrared Spectroscopy (FTIR), Thermogravimetric Analysis (TGA) and X-Ray Diffraction (XRD). Furthermore, Scanning Electron Microscopy (SEM) was performed to analyze surface morphology. Finally, the selected formulation was compared to FDA regulated QC parameters and proved its superiority over conventional market products. Bangladesh Pharmaceutical Journal 24(2): 133-148, 2021

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布洛芬法莫替丁联合定剂量速释片的处方及质量设计评价

非甾体抗炎药(NSAIDs)由于其抗炎和镇痛的特性，经常被医生开处方用于治疗疼痛。长期使用非甾体抗炎药会引起胃肠道(GI)毒性，常见的胃肠道疾病是消化不良、溃疡或出血。因此，生产含有非甾体抗炎药和胃保护剂的局部口服片剂是不可避免的。本实验采用孟加拉国独有的直接加压法制备布洛芬600 mg与法莫替丁20 mg片剂。以聚乙烯吡啶酮(PVPK30) 1% ~ 3%、微晶纤维素(Avicel PH-102) 1% ~ 7%、淀粉-1500 1% ~ 13%为自变量，采用实验设计(DoE)的方法创建了15个试验配方，以脆性和崩解时间分别为0.21 ~ 0.45%和1.8 ~ 20.5 min来描述反应。在15个配方试验(F-1 ~ F-15)中，有7个配方(F-3、F-6、F-8、F-9、F-10、F-13、F-14)符合可接受标准，其中1个配方(F-9)因其崩解、溶出和易碎性较好，自变量为PVP-K30 2.00%， Avicel PH-102 4.75%， Starch-1500 6.5%。体外溶出试验数据拟合为零阶、一阶、Higuchi、Hixson-Crowell和Korsmeyer-Peppas动力学模型。并用傅里叶变换红外光谱(FTIR)、热重分析(TGA)和x射线衍射(XRD)对其相容性进行了研究。此外，用扫描电子显微镜(SEM)分析了表面形貌。最后，将所选配方与FDA规定的QC参数进行比较，证明其优于市场常规产品。孟加拉药学杂志24(2):133-148,2021

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Bangladesh Pharmaceutical Journal

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