Cultivation of Anise Myrtle (Syzygium anisatum)
Yasmina Sultanbawa, Fazal Sultanbawa in Australian Native Plants, 2017
The packaging options for anise myrtle products vary. It is generally dependant on consumer requirements, but also must satisfy/preserve the expected/required quality of the product, which in turn will give the products an extended shelf life. The packaging must also be able to withstand shipping and handling conditions, taking into account export where the product will be subject to wide fluctuations in temperatures. Currently, the most common packaging for dried product is using plastic-lined cardboard cartons. Recent research conducted into alternate packaging for storage of dried product has indicated that the use of a multi-layered foil bag is a far superior material for packaging in regard to extending shelf life and quality retention. Shelf life of dried anise myrtle is very sensitive to correct temperature control and stores best in a dark, dry environment.
The Introduction of New Drugs
Richard Blum, Andrew Herxheimer, Catherine Stenzl, Jasper Woodcock in Pharmaceuticals and Health Policy, 1981
This need for precise data has led to a fundamental change in the pharmaceutical industry and also in clinical research. Any product intended for therapeutic use is now subjected to 3 types of research: Its pharmacological properties are defined by standard methods used in the pharmaceutical industry laboratories. These methods must be sometimes simplified and come to be routines. The stability of the product is examined, for this will determine its shelf life. The finished product used by patients and stocked under normal conditions is investigated to detect possible degradation into toxic or inactive compounds.Toxicity and teratogenicity studies are performed in animals in order to increase the safety of clinical trials in man. Pharmacological and toxicological studies in animals are used to provide as much information as possible before pharmacokinetics and human pharmacology are investigated in healthy volunteers or patients.Only after these studies can clinical studies give information on the efficacy, the side effects and the daily dose of the drug. They can also confirm its therapeutic potential when compared to existing products on the market.
The administration of medicines to children
Evelyne Jacqz-Aigrain, Imti Choonara in Paediatric Clinical Pharmacology, 2021
Extemporaneous preparation describes the manipulation by pharmacists of various drugs and chemicals using traditional compounding techniques to produce suitable medicines when no commercial form is available. The technique is widespread in paediatric practice and may use commercial dosage forms (e.g. tablets, capsules, injections) as starting materials or pure chemical ingredients. Formulations may be published in national reference works and journals or may have been constructed ‘in house’. The physical, chemical and microbiological shelf life of the products may have been established with appropriate tests or may have been assigned arbitrarily. In a recent unpublished UK survey, it was noted that 54% of 112 paediatric extemporaneous formulations had inadequate data on shelf life. Products for individual patients may have little quality assurance whilst those manufactured on a larger scale should at least be checked for chemical composition. Rarely are bioavailability studies performed to demonstrate that extemporaneous preparations have the same absorption characteristics as commercial preparations. This may be especially important if different salts are used e.g. midazolam hydrochloride injection given by the buccal route compared to midazolam maleate buccal solution. Prescribers should be made aware when extemporaneous preparation is necessary and pharmacists should take steps to assure the quality of their products, (http://www.npqa.org.Home/AdvisoryDocuments/StandardsManual [Accessed 3 May 2004]).
Current evidence in the stability of medicines in dose administration aids: implications for patient safety
Published in Expert Opinion on Drug Delivery, 2018
Estela R. García, Stefanie Thalhauser, Hèctor R. Loscertales, Pilar Modamio, Cecilia F. Lastra, Eduardo L. Mariño
Basically, stability problems can appear with drugs sensitive to air, light, and/or moisture. The shelf life of a medicine is attributed to both the stability of the API and the potential interactions, which may occur between the API and the excipients. In general, such shelf-life is determined based on the time a product remains within chemical and physical specifications agreed-upon with regulatory agencies. Chemical instability can affect the potency to be out of the specifications due to a decrease in the drug content and the possible formation of degradation products. Physical instability is associated with any change in the drug product performance (e.g. hardness, friability, disintegration, or dissolution rate), that may cause changes in bioavailability and/or loss of pharmaceutical elegance decreasing patient acceptability. The study of Yang et al. [30] proposed that the moisture uptake of metoprolol tartrate tablets was due to the very hygroscopic excipient, sodium starch glycolate, and not due to the API. This study demonstrates the importance of considering the excipients and dosage form of the drug. Another example of this situation was seen in the case of enalapril maleate with a basic matrix [31]. Additionally, Yamazaki et al. [32] noticed differences in hardness among a brand name and 6 generic unit-dose packages of famotidine orally disintegrating tablets. The observed differences in hardness were presumed to be associated with the additives. This type of studies lead to consider the selection of the preparation according to the hardness when several preparations are available.
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).
Nanocarrier functionalization strategies for targeted drug delivery in skin cancer therapy: current progress and upcoming challenges
Published in Expert Opinion on Drug Delivery, 2023
Leonardo Delello Di Filippo, Mariana Carlomagno de Paula, Jonatas Lobato Duarte, Geanne Aparecida de Paula, Isadora Frigieri, Marlus Chorilli
Lipid nanocarriers such as liposomes and nanoemulsions are cost-effective, easy to produce and scale up formulations, that can also be further modified to target cancer cells, specifically through surface modification, and have been shown to improve drug efficacy and reduce toxicity due to increased tumor penetration and local distribution. However, they can be unstable, and drug leakage can occur during storage. Shelf-life may be compromised and storage condition and stability over time are important key factors to be determine during development. In the other hand, modern lipid nanocarriers such as solid lipid nanoparticles and nanostructured lipid carriers seems to be the most suitable nanosystems to be applied onto the skin, being more stable than conventional colloidal carriers cited earlier, with increased loading capacity and improved stability. However, solid lipid nanoparticles should be properly developed and carefully stored due to instability phenomena related to lipid gelation, recrystallization and drug leakage. This problem is attenuated with nanostructured lipid carriers due to the imperfection formed in the lipid matrix with the addition of a liquid lipid. Overall, lipid nanocarriers present desirable biocompatibility, since they are fabricated using biocompatible lipids, including those present in the human body, such as cholesterol [28,29].
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