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The Non-Prescription Products – Market-Profits and Public Health in Conflict
Published in Mickey C. Smith, E.M. (Mick) Kolassa, Walter Steven Pray, Government, Big Pharma, and the People, 2020
The APhA was greatly vexed by quackery prior to the 1990s. In September 1963, the Journal of the American Pharmaceutical Association carried a cover with the stark words, “MEDICAL QUACKERY” (641). Cover artwork depicted a wolf with the mask of a sheep hovering in front of its face. Inside this issue, APhA published the following description of quackery for its Readers: When an untrue or misleading health claim is deliberately, fraudulently, or pretentiously made for a food, drug, device, or cosmetic, this is quackery. When the maker of the claim has reason to know that it has no foundation, he is practicing quackery. It matters not whether the quackery is practiced by the witch doctor or the licensed medical practitioner; the Indian medicine man or the pharmacist; the proprietary drug manufacturer or the prescription drug manufacturer; the health food manufacturer or the clerk in the health food store; the health lecturer, the self-styled nutritionist, the doorstep diagnostician, the fly-by-night operator of some of our most respected food, drug, device and cosmetic manufacturers—it is still quackery.(641)
Innovations and Future Prospects of Dermal Delivery Systems
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
Rashmi Upasani, Anushree Herwadkar, Neha Singh, Ajay K. Banga
Microsponge® is a proprietary drug delivery system which enables controlled delivery of topical agents. It consists of macroporous microspheres, typically 10 to 25 µ in diameter, loaded with an active agent. These microspheres are interconnected by a myriad of interconnecting voids in a single microsponge, making them amenable to accept a wide variety of substances. When applied to the skin, they release drug in a controlled fashion. Drug release may also occur in response to stimuli, such as rubbing or friction, exposure to skin temperature, pH and moisture (Patel et al. 2012). Traditional dosage forms typically release API in a high concentration over a short duration, which may lead to undesirable side effects such as irritation and rashes. The microsponge delivery technology is designed to release drug gradually over a period of time, thereby providing efficacy with minimal irritation for drugs such as benzoyl peroxide. Improved stability for actives and aesthetic elegance are other benefits conferred by these delivery systems. Also the subcomponents of these systems are non-irritating, non-toxic and non-allergenic. Products based on the Microsponge® delivery system are formulated as gels, liquid, creams or powders and are currently being used in cosmetics, sunscreens, over-the-counter skin care and prescription products to address a variety of skin therapies such as rejuvenation, acne, hyperpigmentation, dark circles and moisturization.
Physicochemical properties of respiratory particles and formulations
Published in Anthony J. Hickey, Heidi M. Mansour, Inhalation Aerosols, 2019
These equations indicate a linear relationship between the β-relaxation molecular mobility and crystallization time. For example, using the data provided in (61), the following value can be determined for a proprietary drug substance labeled there as SSR: ΔH* = 79 kJ/mol, EA = 52 kJ/mol and ΔHʹ = 27 kJ/mol. However, such quantitative data are very rare. For studies on β-relaxations, the crystallization data are usually missing, whereas in others the data on β-relaxations are absent and correlations are sought between crystallization time and α-relaxations. As explained above, the latter is not justified by the crystallization theory, although such correlations can certainly be built because both the crystallization time and time for α-relaxations increase progressively (or even linearly in log coordinates) versus 1/T within a narrow temperature interval around Tm.
Will the new pharmaceutical lipid-aspirin complex formulation restore the once lost trust of aspirin on cardiovascular protection?
Published in Postgraduate Medicine, 2022
Angel Lopez-Candales, Nicholas Norgard
A recent Food and Drug Administration (FDA) approval has launched supplemental New Drug Applications (sNDAs) for Vazalore, the first liquid formulation of a pharmaceutical lipid-aspirin complex (PL-ASA) on the market [1]. The major claim of PL-ASA is its proprietary drug delivery platform that will deliver therapeutic levels of aspirin (ASA) while reducing the risk of gastrointestinal (GI) injury [2]. GI adverse effects such as bleeding and perforation are common side effects associated with ASA use [3]. Many ASA formulations, such as enteric-coated ASA and buffered ASA, have been developed over the years with the expectation that they would be less likely to cause GI bleeding compared to plain immediate-release aspirin. These formulations, however, have not been found to curtail ASA-related GI injury [3]. Additionally, these ASA formulations do not measure up pharmacokinetically or pharmacodynamically as they have been shown to have incomplete absorption, reduced bioavailability, and an impaired platelet inhibitory effect [4]. The novel PL-ASA formulation uses ASA that is noncovalently bound to a pharmaceutical lipid (phosphatidylcholine), which makes it more lipophilic. The increased lipophilicity may help facilitate ASA transit across the GI mucosal layer while reducing gastric surface injury and with no loss in functional bioavailability [5].
Industrializing AI-powered drug discovery: lessons learned from the Patrimony computing platform
Published in Expert Opinion on Drug Discovery, 2022
Mickaël Guedj, Jack Swindle, Antoine Hamon, Sandra Hubert, Emiko Desvaux, Jessica Laplume, Laura Xuereb, Céline Lefebvre, Yannick Haudry, Christine Gabarroca, Audrey Aussy, Laurence Laigle, Isabelle Dupin-Roger, Philippe Moingeon
We separated data sources based upon whether they were either in-house or public, as well as application-agnostic versus application-related. From a core set of in-house/public sources shared for all applications, we subsequently added a data package specific to each single application of interest, making the Patrimony framework both robust and highly flexible. In-house sources broadly used to support Servier’s R&D projects comprised data related to both therapeutic targets being investigated, potentially relevant proprietary drug(s), the phase within research or development as well as the therapeutic area. Core public sources used such as DrugBank or UniProt listed in Supp. Table 2 encompass the existing public knowledge on multiple domains of interest (e.g. biomolecular, pharmacological, clinical) [16–52]. The application-related data package further assembled focused on the disease or set of diseases of interest, which for Servier relates to immuno-inflammatory, oncological, and neurological disorders. The level of implication of various genes and proteins in pathophysiological processes was obtained from multi-omics patient profiling data, by comparing cases and controls in different relevant conditions; either from aggregated statistics or derived from sample-level molecular data (subsequently turned internally into aggregated statistics) retrieved from both public repositories such as GEO or UK Biobank listed Supp. Table 2, partnerships such as public–private IMI projects as well as proprietary experimental data [53–57].