Interchangeability Study of Multisource Paracetamol 500mg Tablets, Produced in Mongolia.

Abstract

To define interchangeability of locally produced Paracetamol (Acetaminophen INN), 500mg tablets. For this purpose Paracetamol 500mg tablets produced by 7 local manufacturers were tested. As a comparator product was used Panadol 500mg, produced by GlaxoSmithKline. Bioequivalence testing was done according to the WHO guideline, Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability, WHO Technical Report Series, №.937, 2006. Based on Biopharmaceutics Classification System Paracetamol tablets bioequilvalency testing was done in vitro through determination of dissolution. In each media of pH 1.2, 4.5 and 6.8 were tested 12 unit samples. All samples were dissolved in three media in not less than 85% of the labelled amount of the paracetamol in 15 minutes. According to the questionnaire, all manufacturers producing Paracetamol tablets answered that the formulation of dosage form was considered the attribute of active pharmaceutical ingredient and excipients and used machinery’s specification. As criteria for choosing the formulation, manufacturers were used pharmacopoeial monograph, stability study data and dissolution results. Mongolian manufacturer’s Paracetamol formulations not contain excipients such as sodium bicarbonate, which is fastening the drug absorption. Three manufacturers use Povidone as a binder, same like comparator product. Most formulations contain Talc and Magnesium stearate as a lubricant mix, when comparator contains Stearic acid and Talc. All formulations contain starch and cellulose, their derivates. Paracetamol 500mg tablets produced by all 7 local manufacturers: LM1, LM2, LM3, LM4, LM5, LM6 and LM7 have dissolution more than 85% in 15 minutes in each of three media. Therefore the dissolution profile comparison with an f2 test is unnecessary [4]. Samples: LM1, LM2, LM3, LM4, LM5, LM6 and LM7 are bioequivalent and could be interchangeable with comparator pharmaceutical product.