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.

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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.

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B. S. Muddukrishna ¹, T. Vamshi Krishna ², Lalit Kumar ², K. Girish Pai ²

Affiliations
1 Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka State, IN
2 Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal -576104, Karnataka State, IN

Abstract

Both competency level and training plays a major role in pharmaceutical industries. Pharmaceutical industry employs technical people from various streams or fields like graduates and post graduates in pharmacy, engineering, science, management etc. On one hand, competency or basic education is a prerequisite for recruiting technical staff to perform assigned job, on the other hand, training the graduates from various streams is an important task for the pharmaceutical industry. Training and development is an ongoing or routine activity in pharma industry so that both the pharma companies and technical staff are up to date and meet the regulatory requirements as per norms. Even the competency level needs to be improved from time to time, like new generation smart phones, where in we need to update our smart phone to include new features or upload new software’s. If this is not done, we become outdated. Likewise, in pharmaceutical industries, both competency level and training and development go parallelly and complimentary to each other. With regulatory agencies (FDAs) becoming increasingly stringent, both competency and training have become integral part of today’s cGMP systems. Therefore, to make the technical staff more competent and well trained, this article gives a detailed insight into competency level and training and development.

Keywords

Competency, Competency Level, Job Responsibility and cGMP.

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