In-vitro Characteristics Comparison of Prepared Immediate Release Tablet of Linagliptin with Innovator Drug and Selected Market Samples of Bangladesh
Shafiqul Islam Sovon1, Habibullah1, Hafizur Rahman2 and Tushar Saha*2
1 Prodcut Development Department, ACI Pharmaceuticals Ltd, Bangladesh
2Research and Development Department, Square Pharmaceuticals Ltd, Bangladesh
Submission: October 18, 2018; Published: November 13, 2018
*Corresponding author: Tushar Saha, Research and Development Department, Square Pharmaceuticals Ltd., Bangladesh
How to cite this article: Shafiqul Islam Sovon, Habibullah, Hafizur Rahman, Tushar Saha. In-vitro Characteristics Comparison of Prepared Immediate
Release Tablet of Linagliptin with Innovator Drug and Selected Market Samples of Bangladesh. J Complement Med Alt Healthcare. 2018; 8(4): 555741.
The aim of the current investigation is to prepare immediate release tablet of Linagliptin and then compare its characteristics with innovator drug and marketed samples of Bangladesh. Direct compression technique was applied to prepare immediate release tablet of Linagliptin and physical characteristics as well as In-vitro dissolution study was performed.Characteristics of prepared tablet, innovator drug and marketed samples all were in official limit. Prepared Linagliptin tablet had better immediate release profile than innovator drug and marketed samples.
Diabetes Mellitus is a chronic and incurable disorder which affects a large number of populations and it is in increasing trend. If it is not managed properly than it will cause clinical, social and economic complications. Diabetic patient has to live with this disease and thus has to take medication during whole life which eventually causes a large amount of cost in drug therapy. Linagliptin is an effective agent which lowers blood glucose level. It is widely used to treat type-2 diabetes and recommended to take once daily. In the meantime, oral route is considered as the most convenient route of medication and getting action in a quickest possible time is one of the main objectives of any medication. Basis on this, an attempt was made to prepare immediate release tablet of Linagliptin and compare its characteristics with innovator drug and marketed samples of the country so that an idea can generate about the quality of prepared tablet.
Materials used in this experiment were of analytical gradeand purchased from local market. Two marketed samples were collected from retail pharmacies of Dhaka city, Bangladesh. Expiry date was checked before collecting marketed samplesso as to ensure that those samples are valid and can be used. Tablets of marketed samples were purchased of same batch number.
At first, drug and other excipients were weighed according to the formula (Table 1) and then blended. After proper blending and mixing direct compression technique was applied to prepare the tablet[3-5].
In-vitro dissolution study was performed by taking tablets in
dissolution media which was 900ml of 0.N HCl (pH 1.2) solution.
Temperature was set 37±0.5℃and rpm was 50.5ml of solution
was taken in a definite time period for analysis and fresh solution
was transferred into the media. Withdrawn solution of samples
was analyzed at 299nm by using UV-visible spectrophotometer.
In-vitro dissolution result of prepared tablet, innovator drug
and marketed samples are presented in Table 3.
From Table-2, it is clear that, prepared Linagliptin tablets (L-
1, L-2 and L-3) have better release profile than the innovators
and marketed samples. 100% drug release was achieved first by
prepared tablets. L-1 achieved it in 30 min and both L-2 and L-3
achieved it in 20min. whereas, in case of marketed and innovator
sample, all took minimum 30min to release 100% of drug.
Immediate release tablet of Linagliptin was formulated
and compare with the innovator drug and marketed samples
successfully in the present study. It was also found that, quality of
the marketed samples were also up to the mark as their obtained
result were satisfactory. Commercialization of the investigated
immediate release tablets of Linagliptin will positively impact our
society as the number of diabetic patients is increasing day by day.