Practices of tablet splitting and dose uniformity of fragments at public hospitals in Ethiopia: A cross-sectional study supported by experimental findings.

OBJECTIVE: To assess the practices and dose uniformity of tablet splitting at selected public hospitals in Northwest Ethiopia. METHODS: A hybrid study method was employed to see the overall practices of tablet splitting. A prospective cross-sectional study was conducted to explore the practices of tablet splitting by administering structured questionnaires to patients and pharmacy professionals. Experimental data on dose and content uniformity of split tablets were obtained from the results of drugs split by study subjects. The content uniformity assay was performed using UV/Vis spectrophotometry. RESULTS: A total of 241 patients and 82 pharmacy professionals participated in the cross-sectional study. The majority of patient participants (51.3%) faced problems while splitting their tablet medications and this had a significant association with the education level of the patients (χ2 = 60.5; p = 0.001). Enteric-coated formulations were dispensed to be split, despite the precaution given by the manufacturers against splitting or crushing these products. Splitting of enteric-coated products accounts for 11% of the total drugs that were dispensed to be taken after a split. The mean of weight variation test for the half tablets does not meet the specifications set in pharmacopoeias when splitting was done by patients. The unscored haloperidol tablets were hard to split and resulted in a significant weight variation of half-tablets than the scored furosemide tablets. Moreover, the weight of 4 out of 20 fragments that were split by patients deviated at least by 15%. CONCLUSIONS: This finding showed that the tablet-splitting practices are poor and do not meet the specifications set by pharmacopoeias. Splitting by patients resulted in significantly higher dose variation and weight loss of fragments than splitting by pharmacists.

Formulation, Optimization and In Vitro Evaluation of Fast Disintegrating Tablets of Salbutamol Sulphate using a Combination of Superdisintegrant and Subliming Agent.

AIM: The present research work was aimed to formulate fast disintegrating tablets (FDTs) of salbutamol sulphate (SBS) using a combination of a superdisintegrant and a subliming agent, optimize the formulation and evaluate the in vitro performance of the developed FDTs. MATERIALS AND METHODS: A formulation of SBS FDT was developed using a combination of superdisintegrant - crospovidone and subliming agent - Ammonium Bicarbonate (AB) in which formulation variables, namely levels of crospovidone and Microcrystalline Cellulose (MCC):Mannitol (MNTL) ratio, were evaluated for their effects on the response variables, disintegration time, hardness, friability and wetting time, of the resulting FDTs. By employing Central Composite Design (CCD) methodology, the FDTs were optimized to achieve optimum levels of the formulation factors. RESULTS: The desired optimum condition was obtained at 7.82% crospovidone and 70% of 1.56:1 MCC: MNTL ratio, while maintaining AB at 5% level for aesthetic reasons. Under the optimized conditions, the disintegration time, hardness, friability, and wetting time were 14.57 ± 0.53 sec, 7.17 ± 0.82 kg/cm2, 0.311% and 13.14 ± 0.69 sec, respectively. The experimentally observed responses were found to be in close agreement with the predicted values for the optimized formulation. Moreover, the validity of the obtained optimal point was confirmed by the low magnitude of percent prediction error (< 5%). CONCLUSION: FDTs of SBS were successfully formulated and optimized using CCD employing a combination of a superdisintegrant and a subliming agent.