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Computational Drug Discovery and Development Along With Their Applications in the Treatment of Women-Associated Cancers
Published in Shazia Rashid, Ankur Saxena, Sabia Rashid, Latest Advances in Diagnosis and Treatment of Women-Associated Cancers, 2022
Rahul Kumar, Rakesh Kumar, Harsh Goel, Somorjit Singh Ningombam, Pranay Tanwar
The stability of drugs is governed by their shelf life under defined environmental conditions. Higher shelf life equates to its long stability in turn, it cannot degrade or oxidize easily so that it can be available for selective target. Thus, it prevents itself from multiple binding and reduce their side effects as well as toxicity [45]. Solubility is another concern due to the availability of different pH range from 2 in the stomach to 7.4 in blood. Generally, salt formation method is used to increase the solubility of drug in the distinct profile of pH [46]. Besides, it is necessary to administered drug through its right path to maximize its potency. Generally, the oral route was preferred over other route of administrations because of its convenient, affordability and safety. A major challenge in this route of administration is the bioavailability of the drug, which defines the presence of active concentration or constituent of administered drug at the site of biological destination [47].
Environmental Protection
Published in Lawrence S. Chan, William C. Tang, Engineering-Medicine, 2019
All medications have clearly indicated “shelf life” which is a federal government regulation mandated by the Food and Drug Administration (FDA 2018). The requirement of shelf life indication is based on the fact that medication, once manufactured, is only stable for certain period of time when stored at certain temperature environment. After that period of shelf life time is passed, the medication may either loss its active ingredient function or be degraded. So the shelf life indication is to ensure that patients will indeed receive functional medication when they need them. Shelf life is tested rigorously during manufactural process to validate the proper function of the medication remain throughout the entire shelf life time span (Puglielli 2014). When medications expire, hospital and outpatient pharmacies will dispose them in a regulated manner to prevent environmental pollution. However, the same expired or unused medications at the hands of patients may not end up in proper disposal pathway. Some of these expired or unused medications may be found in our trash and subsequently in land fill, sewage, surface and ground water, and even in drinking water (Heberer 2002, Bound and Voulvoulis 2005, Sui et al. 2015).
Dispensing in general practice
Published in Conrad Harris, Jane Richards, Prescribing in General Practice, 2018
Many patients will return their unwanted medicines to the doctor’s dispensary for safe disposal. In addition, the dispensary staff may, from time to time, find that some stocks have run out of date and have to be disposed of. Careful monitoring by the dispensary staff should minimize this and in many instances drugs nearing the end of their shelf life can be returned to the wholesaler or manufacturer and reimbursements made. Most FHSAs have in place a system for the collection and safe disposal of unwanted drugs and dispensing doctors should familiarize themselves with these arrangements.
Stability of trastuzumab during nanomedicine formulation using SEC-HPLC coupled with polyacrylamide gel electrophoresis
Published in Pharmaceutical Development and Technology, 2023
Yu Gao, Andrew N. Shelling, David Porter, Euphemia Leung, Zimei Wu
Despite the emerging application of trastuzumab in designing a targeted delivery systems, its ability to withstand various stresses during formulation development and manufacturing is understudied. So far, most of the trastuzumab stability studies simulate a clinical setting and have investigated the in-use stability of the reconstituted solutions (usually below 4 mg/ml) (Kaiser and Kramer 2011; Paul et al. 2013; Nalenz et al. 2018). In addition, the shelf life recommended by the manufacturer is likely based on the risk of bacterial contamination rather than the decline of physicochemical stability (FDA 1998; Paul et al. 2013). However, the stress conditions such as mechanical stress and pH during nanoformulation development are different from those in clinical use. The physicochemical stability of trastuzumab during formulation manipulation and long term storage plays a vital role in determining its biological activity. A loss of the structural integrity of trastuzumab could lead to a compromised binding specificity and affinity, thus a compromised targeting ability in the drug delivery system (Ma et al. 2020).
Stability screening of pharmaceutical cocrystals
Published in Pharmaceutical Development and Technology, 2021
Kenneth C. Waterman, Alisa K. Waterman, Teslin M. Botoy, Jane Li, Fenghe Qiu, Michael Hawley
The Accelerated Stability Assessment Program (ASAP) provides a widely-used approach to the rapid prediction of stability (Waterman et al. 2014; Waterman 2011). Drug substances or drug products are exposed to a range of controlled temperatures and equilibrium relative humidities (RHs) designed to rapidly accelerate the aging process. With ASAP designs, conditions and time points are aimed at reaching an isoconversion point (specification limit) at each unique temperature and RH. The specification limit corresponds to the criteria for acceptance at the end of shelf life based on the limiting factor or factors. Most often the shelf life for drug substances and drug products is limited by growth of individual degradation products, but sometimes, it can be limited by such factors as total impurities, loss of assay or changes in physical characteristics. By knowing the failure points at each condition, a model can be built utilizing a moisture-corrected Arrhenius equation to propagate back to ambient conditions. Since the aim of the present evaluation was to screen cocrystals rather than establish a shelf-life, a simple ASAP design was proposed, as discussed below.
Mucoadhesive gastroretentive microparticulate system for programmed delivery of famotidine and clarithromycin
Published in Journal of Microencapsulation, 2021
Aakanksha Srivastava, Amit Verma, Shivani Saraf, Ankit Jain, Ankita Tiwari, Pritish K. Panda, Sanjay Kumar Jain
The stability of any pharmaceutical product is very crucial over a predetermined period of time, known as the shelf life to ensure the quality attributes which gradually gets affected by the variety of environmental factors such as temperature, humidity, light, microbes, various physicochemical aspects, etc. Degradation is likely to occur under tropical conditions of higher ambient temperature and humidity which often leads to reduced therapeutic efficacy. As per the ICH guidelines, the stability study of drug product is a mandatory parameter to determine the shelf life of the formulation. The optimised formulation of thiolated microspheres was tested for accelerated stability at room conditions (24 ± 2 °C temperature and 45% ± 2% humidity) and at accelerated conditions of temperature and humidity (40 ± 2 °C and 75% ± 2%). The formulations were stored in tightly capped amber glass bottles for the duration of 90days and kept in stability testing chamber (Bio-Technics, India). The samples were withdrawn and analysed significantly for particle size and residual drug content after a span of 30, 60 and 90days.