Pharmaceutical Stability of Brands of Paracetamol Tablets under Different Environmental Conditions (original) (raw)
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Studies of the Effect of Storage Conditions on Some Pharmaceutical Parameters of Powders and Tablets
This study evaluates the effect of storage conditions on some pharmaceutical parameters of powders (paracetamol, corn starch, tragacanth and polyvinyl pyrrolidone) and tablets (paracetamol, metronidazole and vitamin C). For powdered samples, angle of repose, bulk and tapped densities were determined while the tablets were evaluated for hardness, friability and disintegration before and after exposure to various humidity conditions, radiations from telecommunication mast and sunlight at intervals of 24 hrs & 1, 2, 4 and 8 weeks. The results showed a decrease in the angle of repose for paracetamol, corn starch, polyvinyl pyrollidone and tragacanth powders on exposure to sunlight. There was no significant (p>0.05) change in the tapped and bulk densities under the different storage conditions over the storage period. No organoleptic changes were observed for any of the samples stored under the environmental conditions over the two-month period. All the tablets stored over the two-month period conformed to the official BP standard for weight uniformity. Paracetamol tablets exposed to 93% relative humidity (RH) showed significantly lower reduction (P<0.05) in hardness compared to the other storage conditions. On prolonged exposure of paracetamol and metronidazole tablets to radiation from telecommunication mast, there was a reduction in tablet hardness and the tablets became friable. The observations of the present study reconfirm the role of storage conditions in ensuring the physical stability of pharmaceutical powders and tablets.
Review Article on Pharmaceutical Analysis of Tablets According to Standard Pharmacopeias
Journal of emerging technologies and innovative research, 2021
The pharmaceutical tablet must meet specific standards to claim it as a standard drug approval. Pharmaceutical industries test the tablets for maintaining their accuracy following different standard parameters such as identity, strength, quality, purity, and stability, etc. For what why, it is essential to control pharmaceutical processes regardless of the issues that may be addressed. Process control includes inspecting raw materials, controlling processes, and targeting for the finished product. That's why it is significant to monitor the effectiveness of the process control. In connection to this, the adaptation of the production process should comply with the specification as needed, which may also include control of equipment and environment. Pharmaceutical products in the process should be checked appropriately for their identity, strength, quality, and purity and the products are approved or rejected by the quality control unit during the manufacturing process. The highlights of this review are to describe quality control testing of pharmaceutical products by using different instruments for the pharmaceutical industry, according to pharmacopeias.
IN-VITRO QUALITY ANALYSIS OF DIFFERENT BRANDS OF PARACETAMOL TABLET AVAILABLE IN BANGLADESH
Paracetamol is the most prescribed analgesic drug which is used in the treatment of mild to moderate pain relief. The aim of the present study is to examine the physio-chemical parameters of commercially available local brands of paracetamol tablets in Bangladesh. Five brands of paracetamol tablet were explored by testing various parameters according to in-vitro analytical methods. The study parameters were weight variation, friability, disintegration, dissolution and hardness. All brands were tested according to their pharmacopoeia claimed methods to find out their qualities. The requirements of weight variation and friability value were compiled for all brands. According to the BP/IP recommendation for uncoated tablets, fifteen minutes of disintegration time was also complied for all the brands. All brands demonstrated not less than 80% drug release in 45 minute as per BP and not less than 85% in 30 minute as per IP. In case of weight variation, content of each brand was found to be within the range of 95-105%. The hardness of all the brands was found to be in the range of 40-80 N. Again, all brands of paracetamol exhibited less than 1% friability. The findings of the present study suggest that every paracetamol brands which are available in Bangladeshi market supporting the IP/BP requirements. Therefore, as an over-the-counter drug, the consumption of paracetamol is safe and effective for human consumption.
Stability of Pharmaceutical Products
Drug Stability and Chemical Kinetics, 2020
This chapter explains the concept of stability of pharmaceutical products as the extent to which they retain those properties and characteristics within the specified limits, throughout their period of storage and use, possessed at the time of their packaging. The terms like shelf-life and expiry are well defined here. The importance of stability of drug products describes the consequences of instabilities occurring in drug products. Types of stability mainly physical, chemical, microbiological, therapeutic, and toxicological stability have also been discussed concisely. Factors such as moisture, excipients, temperature, pH, oxygen, and light affect the efficacy, quality, and properties of drugs, which makes the drug either a toxic compound or a substance that has no or very little therapeutic activity. Instabilities among different pharmaceutical drug products and substances are explained along with the stability studies to evaluate their degradation behavior upon exposure to various parameters. Such parameters can be controlled according to the stability study type. The testing methods described in this chapter are real-time stability testing, accelerated stability testing, retained sample testing, and cyclic temperature stress testing along with their advantages and disadvantages. The standards for environmental conditions to be provided during such studies are set according to WHO and ICH guidelines. These studies play an important role during drug development stages and are considered as fundamental processes to be carried out for the approval and
Paracetamol is a widely used non-prescription analgesic and antipyretic medicine. It is one of the most commonly used drugs worldwide with non-prescription sales exceeding 25 thousand million doses per year in the United States of America. The study was conducted to assess the comparative in-vitro quality control parameters through the evaluation of weight variation, hardness, friability, disintegration time and dissolution profile among the commercially available tablet brands of paracetamol. To assess the quality, Seven different marketed Paracetamol 500 mg tablet were selected and in-vitro dissolution test, potency, disintegration time was carried out. Other general quality parameters of these tablets like weight variation, hardness, friability were also determined according to established protocols. All the brands comply the requirements of ''United State Pharmacopoeia'' as they showed acceptable weight variation range. Friability of all brands was less than 1%. No significant differences were founding disintegration time as they disintegrated within 5 minutes. In case of dissolution profile all brands showed better dissolution time as they released more than 60% of drug in 40 minute. The hardness of one brand was within the range 6 kg/cm 2 to 10 kg/cm 2. The limitation of the potency must be within 95-105%. All three brands meet this specification. This study suggested that most commercially available Paracetamol tablet in Bangladesh maintain the quality and comply with the USP specifications. It can be concluded that standard quality control parameters always should be maintained not for paracetamol but also for all kinds of medicine for getting better drug products.
2021
Aim: This study was performed to evaluate the quality of five brands of Paracetamol 500mg tablets from different manufacturers. Methods: The general quality parameters of these tablets like weight variation, hardness, thickness, diameter, friability, disintegration time and also dissolution time were evaluated according to the established protocols. For measuring weight variation, an electric analytical balance was used. The hardness, thickness and diameter were determined by an automated hardness tester. Friability was measured by a friabilator. Disintegration time and dissolution time were analyzed by disintegration apparatus and dissolution tester respectively. Results: In this study, all the five brands of the tablets passed the BP or USP standards for in vitro evaluation tests with a very slight deviation. All brands complied with the standards for weight variation (550.1±5.88 mg to 631.1±4.71 mg), hardness (121.60±6.6 N to 220.20±7.6), disintegration time (3 minutes 15 seconds...
A stability study is a routine procedure which ensures the maintenance of pharmaceutical product safety quality and efficacy throughout the shelf life. Stability studies at a developmental stage provides a data base that may be of value in selection adequate formulation to determine shelf life, container closure system and storage conditions for development of new product. In a stability study, the effects of variation in temperature, time, humidity, light intensity and partial vapor pressure on the pharmaceutical product are investigated. These pharmaceutical products are followed by the guidelines issued by International Conference on Harmonization (ICH), World Health Organization (WHO) or other agencies. This review presents the importance of stability testing for any pharmaceutical product. An important point in conducting stability studies are storage conditions which are derived from real climatic conditions. As stability study is tool in cGMP, indirectly to attribute quality product which will increase reputability of company in global market. In this review work we traced the point on recent trends in stability study, recent guidelines, climatic zones, sampling time and plan, estimation of self life, and some stability specifications for pharmaceutical products mentioned.
Quality analysis of different marketed brands of paracetamol available in Bangladesh
International Current Pharmaceutical Journal, 2015
Paracetamol is a widely used analgesic and antipyretic drug worldwide. The present study was conducted to analyze the quality of seven marketed brands of paracetamol tablet formulation manufactured by different multinational and national companies. The tablet formulations of different brands were tested for various parameters like weight variation, hardness, friability, disintegration time and dissolution profile using standard techniques to evaluate their quality. The values were compared with the standards. Weight variation value requirement was complied by all brands. All studied samples except two local products complied with the standard specification for tablet hardness. All brands showed impressive friability values and products of multinational companies comparatively exhibited the highest values. Disintegration time for all brands was within 15 minutes also complying the USP (United State of Pharmacopeia) recommendation. Moreover, the release rate of different brands of paracetamol was satisfactory within 45 minutes and ranged from 79.82% to 103.53%. Therefore, it can be concluded that almost all the brands of paracetamol that are available in Bangladesh meet the USP specification for quality control analysis.
An Overview on Formulation and Evaluation Aspects of Tablets
Asian Journal of Dental and Health Sciences
Nothing in this world is stable and ever accepted. Change is the requirement of nature for the sake of adaptability. However, the pharmaceutical world is also not far off from this change. Technical advancement in pharma world also leads to the development of new dosages forms. This leads to the replacement of the older dosages forms with the newer once. But for the tablet dosages forms this replacement is substituted with modifications. On the top of it the availability of numerous evaluation parameters provides these new modifications in tablets a clear cut demonstration idea. Tablets are defined as solid unit dosage form of medicaments intended for oral use. They became most popular as they were easy in preparation compared to any other type of dosage forms. But the major drawback exists in its manufacturing. If any minor problem occurs during their manufacturing then the whole batch of the unit should be discarded. It is necessary to avoid any sort of errors during its manufactu...