Drug development and industrial pharmacy
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Emulsions for parenteral nutrition loaded with drugs are used for optimized drug delivery, but in case of poorly oil soluble drugs, the injection volume can be too large when using commercial 10-20% oil emulsions. To reduce the injection volume, the feasibility of producing injectable, physically stable concentrated emulsions up to 40% oil content was investigated. Emulsions were made from fish oil, stabilized with egg lecithin, using high-pressure homogenization. ⋯ Despite the high oil concentration, the viscosity of the nanoemulsions was sufficiently low for injection. The short-term storage study showed physical stability for 1 month. A concentrated nanoemulsion base formulation from regulatory accepted excipients is now available, ready for loading with drugs.
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A single-dose glass ampoule was developed for ease of administration. When glass ampoules are opened, resulting in contamination by particulate matter. Reducing its contamination may minimize the risk in patients due to particulates. ⋯ The total weights were reduced to 53.6 and 50.6%, respectively for 1 and 2 mL-ampoules, compared to opening by hand. The loss of ampoule contents on opening by the VM was 6.50 and 4.67% for 1 and 2 mL-ampoules, respectively. As a result, the VM efficiently reduced glass particulate contamination and the evaluation methods used were appropriate for quantifying these levels of contamination.
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Randomized Controlled Trial Comparative Study Clinical Trial
Comparison of a novel fast-dissolving acetaminophen tablet formulation (FD-APAP) and standard acetaminophen tablets using gamma scintigraphy and pharmacokinetic studies.
Acetaminophen (paracetamol, APAP) is widely used to relieve mild-to-moderate pain and reduce fever. Absorption of the drug can be impacted by dosage form; this may have implications for pain relief in some individuals, potentially accounting for suboptimal efficacy in analgesia. ⋯ Compared with standard acetaminophen, the FD-APAP formulation results in significantly faster onset of disintegration and more rapid absorption.
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Counterfeit drug products have become a major problem worldwide and a number of techniques to detect counterfeit products or reduce the potential for counterfeiting have been investigated. This study examined the use of stable isotope-labeled excipients in solid dosage forms as a method to identify drug products and to detect counterfeits. ⋯ It was possible to use the isotope ratios to differentiate between specific batches of granules, demonstrating the potential of this technique for in-product, batch-specific identification.
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Microcrystalline cellulose (MCC) is the most important pelletization aid in extrusion/spheronization. Because of known disadvantages, the search for substitutes is ongoing. In this context, crospovidone has proven to offer substantial advantages as pelletization aid because of its ability to turn low-soluble active ingredients into fast-dissolving stable pellets. ⋯ Crospovidone shows an excellent behavior as pelletization aid and produces fast-releasing pellets even with low-soluble APIs.