Informatics Publishing Limited

K. Girish Pai ¹, T. Vamshi Krishna ¹, Lalit Kumar ¹, M. Sreenivasa Reddy ¹, Shreya Singh ¹, V. Vibha ¹

Affiliations
1 Department of Pharmaceutics, MCOPS, Manipal University, Manipal, Karnataka-576104, IN

Abstract

The objective of the study was to assess whether few marketed brands of Salbutamol sulphate syrup IP was within the limits as specified in Indian Pharmacopoeia with respect to selected physical parameters. A study was carried out using two different brands coded as brand A and B for Salbutamol sulphate syrup IP. In this study, selected brands were well known brands and a comparative study was planned. Salbutamol is a short acting β2 adrenergic receptor agonist used commonly for the relief of bronchospasm in conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD). In the present study, three different batches each of brand A and brand B were procured randomly from the medical shop. The tests that were performed included the visual inspection or appearance of product, pH measurement, extractable volume, primary labeling quality and checking of text matter on primary label. From the study, it was found that both the brands were comparable with respect to various physical parameters; however brand B was chosen as best since the results for all three batches were consistent and uniform. Brand A was not user friendly since there was difficulty in opening cap as it is uncomfortable for a patient suffering from asthma. These types of problems sometimes receive market complaints as well.

Keywords

Salbutamol Sulphate, Copd, Extractable Volume, Text Matter.

Full Text

     

T. Vamshi Krishna ¹, K. Girish Pai ², G. Hemanth ², A. Damodaram ², M. Sreenivasa Reddy ²

Affiliations
1 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Udupi, Karnataka, IN
2 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal, Karnataka, IN

Abstract

The objective of this study was to compare various physical parameters of four different marketed brands of Paracetamol 500mg uncoated tablets and to verify the compliance of these physical parameters with respect to the standards as per Indian Pharmacopoeia (IP).The pre-requisite is that uncoated tablets should be free of dust without presence of any black particles and better tablet finish. Four brands of Paracetamol tablets manufactured by different manufacturers and but with similar primary package i.e. tablets packed in Blister were chosen and labelled as Brand A, B, C and D respectively. The tablets were randomly purchased from pharmacy outlets. The tablets were subjected to various physical evaluation tests like tablet appearance or description, weight variation, hardness, dissolution, disintegration time and friability. After performing the tests and comparing the results obtained, it was observed that all the four brands of Paracetamol tablets passed the Quality Control (QC) tests as per IP. However, the brands B and C showed poor physical appearance with observations like presence of dust, poor finishing, few chipped edges etc as compared to brands A and D. Among the brands A and D, brand D showed better results in terms of tablet appearance or description, weight variation, hardness, dissolution, disintegration time and friability. Thus brand D is concluded as best brand among four selected brands. The above said defects can be avoided by having strong in-process Quality Assurance personnel in the shop floor during manufacturing activity. A thorough monitoring system will avoid these observations and customer shall get a best tablet for medication.

Keywords

Paracetamol, Appearance, Weight Variation, Friability, Hardness, Disintegration, Dissolution.

Full Text

     

Rakshith Shetty ¹, Vaishnavi Tallapaneni ², M. Sreenivasa Reddy ², Nayanabhirama Udupa ², Srinivas Mutalik ², Vijay Kulkarni ¹, Vinay Rao ¹, Aravind Kumar Gurram ¹

Affiliations
1 STEER Life India Pvt Ltd, Bengaluru 560058, Karnataka State, IN
2 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 576104, Karnataka State, IN

Abstract

Lumefantrine is a BCS class -II drug having a poor aqueous solubility. There is a need for improvement in solubility, in order to enhance the therapeutic efficacy and reduce the dose. Hence in the present work, the solubility of lumefantrine is enhanced by formulating solid dispersions of lumefantrine using a hot melt extrusion process in a twin-screw processor using three different polymers such as Kollidon VA64, Soluplus and HPMC AS at a weight ratio of 1:2, 1:3 and 1:4, processed at different barrel temperatures and screw speeds. The obtained solid dispersions were characterized by differential scanning calorimetry and solubility studies. Solid dispersions prepared with KollidonVA64 and Soluplus showed a clear extrudate indicating a complete amorphous conversion of the lumefantrine at all the three ratios evaluated. Increase in polymer concentration, increased the solubility of the lumefantrine. With Kollidon VA 64 and Soluplus, lumefantrine to polymer ratio of 1:4 showed the highest increase in solubility, compared to that of the pure lumefantrine.

Keywords

Lumefantrine, Polymers, Twin Screw Extrusion, Solid Dispersion, Solubility.

Full Text