Quality of Dicloxacillin Sodium in the Forms of Dry Powder for Oral Suspension and Capsules Storied at the Storage Rooms of Subdistrict Health Promoting Hospitals at Tak Bai District, Narathiwat
Main Article Content
Abstract
Objective: To determine the quality of dicloxacillin sodium in the forms of dry powder for liquid preparation and capsules in the actual conditions in the storage room of Subdistrict Health Promotion Hospitals in Tak Bai District, Narathiwat. Method: This study was action research by storing one brand of dry powder of dicloxacillin sodium and one brands of capsules in the same medication in one room with air conditioner and the other without air conditioner for a period of 8 months. The study sampled and analyzed medication according to the selected standard in the USP34 standards at 0, 4 and 8 months. The study also monitored temperature and humidity of the rooms in order to evaluate the effect of storage conditions on drug stability. The study then suggested the improvement of inventory management. Results: Quality of the drugs in both storage rooms remained throughout 8 months of study according to the selected standard assessment. At the same time, temperature and relative humidity of the storage room without air conditioning were higher than the conditions specified on drug label. It is assumed that having the appropriate primary packaging will prevent the degradation of the drug from the main factors, i.e., moisture. Conclusion: Data on the risk factors of drug instability both from the pharmaceuticals and the storage conditions are essential. In addition, the conditions specified on the label should be used as criteria to assess the risk and suggest risk reduction.
Article Details
ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
References
Anonymous. Annex 10: Stability testing of active pharmaceutical ingredients and finished pharmaceu tical products [online].2018 [cited Jun 3, 2019]. Available from: www.ich.org/fileadmin/Public_Web_ Site/ICH_Products/Guidelines/Quality/Q1F/Stability_Guideline_WHO_2018.pdf
Bott RF, Oliveira WP.Storage conditions for stability testing of pharmaceuticals in hot and humid regions . Drug Dev Ind Pharm 2007; 33: 393-401.
Kumar N, Jha A. Temperature excursion management: A novel approach of quality system in pharmaceutical industry. Saudi Pharm J 2017; 25 : 176-83.
Anonymous. Annex 9 Guide to good storage practices for pharmaceuticals1 [online]. 2003 [cited Jun 3, 2019]. Available from: www.who.int/medi cines/areas/quality_safety/quality_assurance/Guide GoodStoragePracticesTRS908Annex9.pdf?ua=1
Templeton AC, Han YHR, Mahajan R, Chern RT, Reed RA. Rapid headspace oxygen analysis for pharmaceutical packaging applications. Pharm Tec hnol 2002; 26: 44-61.
Waterman KC, Macdonald BC. Packaging selection for moisture protection for solid, oral drug products. J Pharm Sci 2010; 99: 4437-52.
Zhou D, Porter WR, Zhang GGZ. Drug stability and degradation studies. In Qui Y, editors. Developing solid oral dosage forms. Cambridge, MA: Academic Press; 2008. p.87-124.