POST MARKETING INVITRO DISSOLUTION STUDY OF LORATADINE TABLET (10 MG)

Abstract

Objective: Comparative study is performed to determine and compare the physicochemical characteristics of different pharmaceuticals (usually local products compare with multinational products) directed according to standards given in United States pharmacopoeia and British pharmacopoeia. Background: Loratadine is currently used to comfort symptoms of inflammation of nose lining, and various skin conditions. Evaluation of loratadine against placebo in the treatment of inflammation of nose lining in which loratadine was administered to patients for two to three weeks given at the dose it produces therapeutic effects. In such study loratadine was found to be more effective as compared to placebo and is efficacy is similar to that of other anti-histaminic drugs. Methodology: Distilled water, Softin, Qulor, Tea extract. Test performed in order to conduct a comparative study between 2 brands of active Loratadine that is available in market in water and tea extract as medium. The first brand that is Softin is considered as LORA 1, the second brand that is Qulor is considered as LORA 2,The LORA 1 is manufactured according to the BP and USP. The LORA 2 is manufactured according to the USP. The dissolution test is performed to determine the physicochemical parameters of available brands. Results: We test dissolution of both brands in gastric fluid medium (pH 1.2) and in green tea extract. We obtain % dissolution in gastric fluid of lora-1 is 47.24%, 8.66%, 96.06%, 185.03%, 92.91% within 60 minutes and average dissolution % is 85.98% which is within limits and % dissolution of lora-2 is  32.28%, 91.33%, 162.99%, 250.39%. 451.96, within 60 minutes and average dissolution % are 197.7% which is also within in limits. In green tea medium, % dissolution of lora-1 17.32%, 27.55%, 15.74%, 16.53%, 86.61% within 60 minutes and average dissolution % are 32.75% which is less than 80% and % dissolution of lora-2 29.92%. 55.11%, 224.40%, 245.66%, 266.14% within 60 minutes and average dissolution % are 164.2%. Conclusion: Results and graphical representation are clearly show the point that gastric fluid is the best medium to be used with loratadine brands lora-1 and lora-2 tablets for the purpose of achieving its prompt and maximum effect. In green tea medium lora-1 has not good dissolution while lora-2 show good dissolution may be due difference in excipients.

keywords: Loratidine, dissolution, comparative study