Splitting Tablets of Drugs with Narrow Therapeutic Index and Having Low Dose: Dose Accuracy and Stability of Split 3 mg Warfarin Sodium Tablets
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Abstract
Objective: To evaluate dose accuracy of the split 3 mg Warfarin sodium (WS) tablets and to study their stability when stored at the accelerated and normal conditions. Methods: The research studied the split of WS tablets by hand and by cutting apparatus. The study measured weight of the split tablets and assessed factors affecting the amount of WS in split tablets including 1) consistency of WS in the split tablet units 2) the accuracy of the dose in each split units from the examination of content uniformity using the method of USP 37 and 3) the dissolution of WS from split tablet units. For the stability study, whole tablets and split tablets were kept in controlled cabinets under accelerated conditions and normal conditions similar to storage in household. The study determined the amount of WS in tablets and their dissolution when kept at 2 or 4 weeks. Results The split tablets had a variation of amount of WS with one out of 5 split tablets having %label amount of 95.0–105. This may result from non-uniformity of WS among whole tablets, and heterogeneity of drugs within a whole tablet. Dissolution declined in both whole and slit tablets kept at the studied conditions. However, there was no chemical degradation. Change in dissolution may be resulted from change in the physical property after moisture exposure. Conclusion: Splitting of this lot of WS tablets obtained split tablets with large erratic dose which could be considered as a risk for patients. Furthermore, taking the tablets out of original packages or keeping the whole tablets or split tablets in conditions unprotected from moisture should be avoided.
Article Details
ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
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