A Systematic Investigation and Suggested Remedies for a Defective Marketed Solid Dosage Form.

Abstract

An ideal tablet should be of high quality and devoid of flaws. Tablet defects can lead to therapeutic failure and reduce the patient compliance in case of clinical perspective whereas it also imparts financial burden, loss of production time and reputation of the company. The research was carried out to investigate and find out the possible root causes of the broken tablet within the intact blister. Oral dosage forms were visually inspected in a hospital pharmacy in the Udupi district, using a validated checklist. A powdered uncoated Fluconazole tablet was found within the intact blister pocket of 1’s pack. A case study was formulated comprising of the dosage form, generic name, therapeutic category, probable root causes, defects, category of complaint, probable root causes and remediation and clinical significance. This unique outcome of the work can be used to train the health professionals which will further help them in avoiding such defects and defective products reaching the patients. Such defects can be bypassed by giving effective training to the staff using real-life case studies, taking corrective and preventive actions and conducting adequate in-process quality checks before releasing the products into the market. The use of such case studies will be effective in learning better and developing their skills in problem-solving and decision-making in ambiguous/complex situations.