Current Issue : July - September Volume : 2014 Issue Number : 3 Articles : 5 Articles
Nasal drug delivery can be assessed by a variety of means and regulatory\nagencies, e.g., the Food and Drug Administration (FDA) and the European Medicines\nAgency (EMA) have published a set of guidelines and regulations proposing in vitro test\nmethods for the characterization of nasal drug products. This article gives a summary of\nthe FDA and EMA requirements regarding the determination of droplet size distribution\n(DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and\ndiscusses the analytical challenges that can occur when performing these measurements.\nIn order to support findings from the literature, studies were performed using a standard\nnasal spray pump and aqueous model formulations. The aim was to identify possible\nmethod-, device- and formulation-dependent influencing factors. The literature review, as\nwell as the results from the studies show that DSD, plume geometry and spray pattern are\ninfluenced by, e.g., the viscosity of the solution, the design of the device and the actuation\nparameters, particularly the stroke length, actuation velocity and actuation force.\nThe dominant factor influencing shot weights, however, is the adjustment of the actuation\nparameters, especially stroke length and actuation velocity. Consequently, for routine\nmeasurements assuring, e.g., the quality of a solution nasal spray or, for in vitro\nbioequivalence studies, the critical parameters, have to be identified and considered in\nmethod development in order to obtain reproducible and reliable results....
B-cell epitope prediction can enable novel pharmaceutical product development. However, a mechanistically framed consensus\nhas yet to emerge on benchmarking such prediction, thus presenting an opportunity to establish standards of practice that\ncircumvent epistemic inconsistencies of casting the epitope prediction task as a binary-classification problem. As an alternative\nto conventional dichotomous qualitative benchmark data, quantitative dose-response data on antibody-mediated biological effects\nare more meaningful from an information-theoretic perspective in the sense that such effects may be expressed as probabilities\n(e.g., of functional inhibition by antibody) for which the Shannon information entropy (SIE) can be evaluated as a measure of\ninformativeness. Accordingly, half-maximal biological effects (e.g., at median inhibitory concentrations of antibody) correspond\nto maximally informative data while undetectable and maximal biological effects correspond to minimally informative data. This\napplies to benchmarking B-cell epitope prediction for the design of peptide-based immunogens that elicit antipeptide antibodies\nwith functionally relevant cross-reactivity. Presently, the Immune Epitope Database (IEDB) contains relatively few quantitative\ndose-response data on such cross-reactivity. Only a small fraction of these IEDB data is maximally informative, and many more of\nthem are minimally informative (i.e., with zero SIE). Nevertheless, the numerous qualitative data in IEDB suggest how to overcome\nthe paucity of informative benchmark data....
The retention of the enzyme activity of alcohol dehydrogenase (ADH) has been\nstudied in various drying processes such as spray drying. The aim of this study is to\nencapsulate ADH in mannitol, either with or without additive in order to limit the thermal\ndenaturation of the enzyme during the drying process. The retention of ADH activity was\ninvestigated at different drying temperatures. When mannitol was used, the encapsulated\nADH was found inactive in all the dried powders. This is presumably due to the quick\ncrystallization of mannitol during spray drying that resulted in the impairment of enzyme\nprotection ability in comparison to its amorphous form. Maltodextin (dextrose equivalent = 11)\nwas used to reduce the crystallization of mannitol. The addition of maltodextrin\nincreased ADH activity and drastically changed the powder X-ray diffractogram of the\nspray-dried powders....
The objective of this work was to study the coating process of nifedipine extended release pellets using Opadry and Opadry II, in a\nfluid bed coater with aWurster insert.The coating process was studied using a complete experimental design of two factors at two\nlevels for each polymer.The variables studied were the inlet air temperature and the coating suspension flow rate. The agglomerate\nfraction and coating efficiency were the analyzed response variables. The air temperature was the variable that most influenced\nthe coating efficiency for both polymers. In addition, a study of the dissolution profiles of coated and uncoated pellets using 0.5%\nsodium lauryl sulfate in simulated gastric fluid without enzymes (pH 1.2) was conducted. The results showed a prolonged release\nprofile for the coated and uncoated pellets that was very similar to the standards established by the U.S. Pharmacopoeia. The drug\ncontent and the release profiles were not significantly affected by storage at 40�°C and 75%relative humidity.However, when exposed\nto direct sunlight and fluorescent light (light from fluorescent bulbs), the coated pellets lost only 5% of the drug content, while the\nuncoated ones lost more than 35%; furthermore, the dissolution profile of the uncoated pellets was faster....
One of the challenging tasks for present day’s formulation scientists in pharmaceutical product development wing is to develop a high quality drug product within a short span of time. This requires acquisition of specific domain of knowledge and years of experience. One such system is knowledge based systems (KB systems) which is a computerized artificial expert system to encode, archive and utilize the past domain knowledge data for problem solving and decision making in pharmaceutical product development. It will assist the formulator to learn and to identify intricate formulation and process variables for efficient product development. Therefore one can witness increased productivity, consistency and quality product. In the text authors have enlightened various types of experts system pertained to KB and their utility in the pharmaceutical production with relevant examples....
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