The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations (original) (raw)
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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
Stability of Pharmaceutical Preparations
MINAR International Journal of Applied Sciences and Technology
Pharmaceutical product must be chemically, physically and therapeutically stable to ensure the health and preventive aspect. We have to study the effect of many factors on drug formulation as well as packaging and storage. Stability of pharmaceutical preparation act as the identity card of the drug to reach the pharmacy, the hospital, and the consumer in general, without this identity, it is not possible to approve the drug healthily or in circulation. Furthermore, stability mentoring of pharmaceutical preparations provides information about many physiochemical parameters as rate, and order of decomposition reaction of active ingredients, or the expected interaction with the other ingredients. In order to follow the stability of any pharmaceutical product, an analytical method must be available and convenient for the chemical nature of the product, the analytical procedure must be validated by the accuracy, precision, recovery as well as sensitivity, selectivity proved with statisti...
Guidelines on Stability Studies of Pharmaceutical Products and Shelf Life Estimation
International Journal of Advances in Pharmacy and Biotechnology, 2020
The primary aim of carrying out stability studies of drug products is to determine the expiration date and to promise the product standardized for efficacy, safety and elegance throughout its shelf-life. ICH, WHO, ASEAN and separate agencies issued the guidelines for stability studies, which are requisite to be demeanour in a deliberate way and are wise as prerequisite for regulatory fill and approval of any medicinal product. Stability investigating provides the collection on stability strikingness of drug product including the belief of various environmental factors, packaging method etc. ensuring that it remain within planted specification to hold its degree and present the desirable performance consistently and in a way comforting for the usefulness of its intentional use all finished the retest or expiry date. This canvas types of stability studies, guidelines issue for stability investigation and forecasting of shelf life of medicine products along with flowing trends in stability studies.
Development of stability indicating studies for pharmaceutical products: an innovative step
A stability study is a routine procedure which ensures the maintenance of pharmaceutical product safety, quality and efficacy throughout the shelf life. These pharmaceutical products are followed by the guidelines issued by International Conference on Harmonization (ICH), World Health Organization (WHO) or other agencies. Stability testing provides evidence that the quality of a drug substance or drug product under the influence of various environmental factors changes with time. Importance of various methods followed for stability testing of pharmaceutical products, guidelines issued for stability testing and other aspects related to stability of pharmaceutical products have been presented in a concise manner in the present review. This review article includes introduction about stability studies types of stability studies and chemical reactions takes place during degradation etc. This article also includes the forced degradation studies and shelf life estimation of pharmaceutical products.
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.
Stability profiles of drug products extended beyond labeled expiration dates
Journal of pharmaceutical sciences, 2006
The American Medical Association has questioned whether expiration dating markedly underestimates the actual shelf life of drug products. Results from the shelf life extension program (SLEP) have been evaluated to provide extensive data to address this issue. The SLEP has been administered by the Food and Drug Administration for the United States Department of Defense (DOD) for 20 years. This program probably contains the most extensive source of pharmaceutical stability data extant. This report summarizes extended stability profiles for 122 different drug products (3005 different lots). The drug products were categorized into five groups based on incidence of initial extension failures and termination failures (extended lot eventually failed upon re-testing). Based on testing and stability assessment, 88% of the lots were extended at least 1 year beyond their original expiration date for an average extension of 66 months, but the additional stability period was highly variable. The...
International Journal of Pharmaceutics, 2018
Different regulatory guidelines recommend establishing stability profile of pharmaceuticals at the time of drug development. The expiry date, retesting period and storage conditions of active drugs or products are established through stability analysis. Different regulatory guidelines exist for stability testing of pharmaceuticals. Mostly, ICH stability guidelines are followed in practice. ICH guideline recommends to validate stability indicating method using forced degradation samples that contains all possible degradation impurities. ICH guidelines provide general recommendations for inclusion of stability indicating parameters in a stability testing protocol. However, those guidelines do not provide specific requirements and experimental methodology to be followed for stability studies. Due to this gap, often confusion arises in the scientific community in designing stability testing protocol. Therefore, significant variations are observed in reported literature in selection of stability indicating parameters. Procedural dissimilarity amongst reported stability studies is also evident. This review discusses the regulatory guidelines and procedures to follow in performing stability testing of pharmaceuticals. Scope of this review also includes recommendations on practical approaches for designing stability testing protocol to fulfill current regulatory requirements for drug substances and their formulations.
Long-term stability study of drug products and out-of-specification test results
Accreditation and Quality Assurance, 2011
A metrological approach for investigating outof-specification (OOS) test results in long-term stability study of drug products was used. It is shown that OOS test results can indicate an actual change in a measured property of a product or be metrologically related with a certain confidence probability, i.e., be caused by the measurement problems, while the product still meets the quality requirements at the time of testing. As examples, results of testing sodium chloride injections in 500-mL plastic containers and of epinephrine (L-adrenaline) injections in 1-mL ampoules were discussed. Regression analysis of the data was performed, as well as warning and action lines for shelf life of the products calculated for relevant measurement uncertainties and confidence probabilities. Producer's and consumer's risks of the established shelf life values were also estimated.