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Monographs of Topical Drugs that Have Caused Contact Allergy/Allergic Contact Dermatitis
Published in Anton C. de Groot, Monographs in Contact Allergy, 2021
From January 1990 to June 2008, in Leuven, Belgium, 315 patients were diagnosed with contact allergy to/allergic contact dermatitis from corticosteroids (CSs) from routine patch testing with a baseline series including tixocortol pivalate, budesonide, hydrocortisone butyrate and prednisone caproate, patch testing with patients’ own CS preparations, and testing those with proven contact allergy to a corticosteroid or strongly suspected of CS allergy later with a series of 66 CSs, including two sex hormones (progesterone and testosterone). 71% of the patients had relevant reactions, but these were not specified. In this group of 315 CS allergic patients, 48 had positive patch tests to hydrocortisone acetate 0.1% alc. It is unknown how many of these reactions were caused by the use of a pharmaceutical product containing hydrocortisone acetate and how many were cross-reactions to other corticosteroids (13; possibly overlap with refs. 1 and 2).
Regulatory Standards for Approval of Topical Dermatological Drug Products
Published in Tapash K. Ghosh, Dermal Drug Delivery, 2020
April C. Braddy, Dale P. Conner
The Federal Food, Drug, and Cosmetic Act (FFD&C Act) of 1938 requires that safety be established for all drug products prior to marketing approval. It wasn’t until the 1962 Kefauver-Harris Amendments that a drug product must be shown to be efficacious as well as safe (U.S. FDA 2012b). In between that 24-year time period, numerous drug products were approved. In order to address this problem of potentially ineffective drugs, in 1966 the U.S. FDA commissioned the National Academy of Sciences/National Research Council to evaluate the efficacy of all drug products approved between 1938 and 1962. Based on the results of this extensive project, many products were deemed effective and thus classified as drug efficacy study implementation (DESI) drugs (Federal Register 2012 & National Academy of Sciences 1972). This listing includes all types of topical dermatological drug products. In fact, in 1953, the first topical corticosteroid, Hydrocortisone Acetate Ointment (Cortef Acetate), was approved by the U.S. FDA based on an NDA submission. The application for this product was not approved based on comparative clinical trials. Hydrocortisone Acetate Ointment is currently listed as a DESI (Drug Efficacy Study Implementation) drug product for the 1%, 1.5% and 2.5% dosage strengths. According to the current federal regulations, 21 Code of Federal Regulations (CFR) 320.22 (c) (U.S. Code of Federal Regulations 2013), a waiver from in vivo bioavailability and BE study requirements may be granted for a DESI drug product.
Nina: The Use of Potent Opioids in a Complex Chronic Pain Patient
Published in Michael S. Margoles, Richard Weiner, Chronic PAIN, 2019
Her next visit was on 5/19/95. The patient was noted to be alert and coherent, with no slurred speech, good cognition, no evidence of drug toxicity, and comprehended what I was saying. Her pain was rated at about 75% of the worst she ever had. She indicated that she could sit for 30 minutes, stand for 30 minutes, and walk for 90 minutes. The intensity of the pain was moderate and the frequency was constant. The pain was depicted on both sides in the lower neck, paraspinally from T5 to T8 on the right side with noticeable intensity, and from T10 to L2 bilaterally with minimal intensity. At that visit, the patient was premedicated with 4 mg of Dilaudid® and 12.5 mg of Phenergan®. She was also premedicated with 25 mg of hydrocortisone acetate. Trigger point injections were carried out to the right T7, T8, and T9 multifidus. Before the third trigger point was carried out, the patient had a classic osteopathic release procedure performed from T2 to T7. She then had a trigger point injection into the right-sided multifidus at T10. The patient was noted to be conversant but somewhat light-headed, and therefore 0.13 cc (0.4 mg/ml) of Narcan® was administered subcutaneously. Immediately after that, the patient was noted to be conversant, had a mild flush on her face and low back, and was noted to be alert. The patient inquired about using larger dose B-complex shots at that time, and I told her it was okay to be on the 3-cc shots, and when she felt she was doing better, she could put one day between the shots.
ALSUntangled #65: glucocorticoid corticosteroids
Published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 2023
Jill Ann Goslinga, Mark Terrelonge, Richard Bedlack, Paul Barkhaus, Benjamin Barnes, Tulio Bertorini, Mark Bromberg, Gregory Carter, Amy Chen, Jesse Crayle, Mazen Dimachkie, Leanne Jiang, Gleb Levitsky, Isaac Lund, Sarah Martin, Christopher Mcdermott, Gary Pattee, Kaitlyn Pierce, Dylan Ratner, Lenka Slachtova, Yuyao Sun, Paul Wicks
Many of the initial case series of PALS being treated with corticosteroids are from the 1950s and 1960s. One case series followed two patients who were treated with an “adequate” dose of intramuscular cortisone, 200 mg on day one, then 100 mg daily until 3 grams were fully administered. Both patients had continued progression of their disease despite therapy (22). Another report described a patient who received intrathecal injections of hydrocortisone acetate for over a year (initially every other day for one week, then approximately weekly for 2 months, then every 2 months for 10 months, then once 6 months later) with doses ranging from 32 to 75 mg, along with a specialized diet of “unsalted fresh food” and a vitamin regimen consisting of vitamin A, vitamin D, thiamine, riboflavin, niacinamide, and ascorbic acid. The patient had a baseline disease course that had been slowly progressive for 15 years, and he primarily had diffuse fasciculations in his back and legs, left greater than right lower extremity weakness, and fluctuating lower extremity Babinski signs with no cranial nerve or upper extremity symptoms. Throughout the patient’s treatment course, he noted “improvement [continuing] with each spinal”. At the end of 2.5 years, his exam was largely stable (23). Given his slow 15 years of symptom progression prior to therapy, it is difficult to conclude that two-and-a-half years of stability represented a true slowing of his progression.
Allergy and Dry Eye Disease
Published in Ocular Immunology and Inflammation, 2021
Andrea Leonardi, Rocco Luigi Modugno, Elena Salami
Topical steroids are the most effective drugs to address inflammation of the ocular surface. Low-penetrance topical steroids (e.g. loteprednol, fluorometholone, hydrocortisone acetate, clobetasone, desonide, rimexolone) should be preferred reserving high-penetrance steroids (e.g. prednisolone, dexamethasone, or betamethasone) when the previous ones are ineffective. Different schemes of administration can be adopted, even though a pulsed administration for short periods should be preferred (three to five times a day for no longer than 3–5 days): this will exert an anti-inflammatory effect while reducing the risk of long-term adverse events, especially in children (e.g. steroid-induced cataract and glaucoma). Short-pulse systemic steroids may be also necessary as a temporary measure in the most severe cases.65–67
Mechanisms of increased bioavailability through amorphous solid dispersions: a review
Published in Drug Delivery, 2020
Andreas Schittny, Jörg Huwyler, Maxim Puchkov
Several experimental studies highlighted the role of molecular interactions to inhibit crystallization. In a work by Kojima et al. (2012), ASDs from mefenamic acid in Eudragit EPO (butyl methacrylate-co-(2-demethylaminoethyl) methacrylate-co-methyl methacrylate) showed that upon dissolution, a significant increase in solubility was achieved along with solution stabilization. Different molecular interaction between drug and polymer (ionic, hydrogen bonds, or hydrophobic), especially between the carboxyl group in mefenamic acid and the aminoalkyl groups in Eudragit EPO, were observed. Authors conclude that supersaturation is most likely facilitated by these interactions. Furthermore, the authors reported enhanced dissolution profiles for Eudragit EPO with the NSAIDs (non-steroidal anti-inflammatory drugs) indomethacin and piroxicam. There are also indications that a nonspecific binding can result in a crystallization inhibition effect (Baghel et al., 2018): an NMR study on nimodipine with PVP (polyvinylpyrrolidone) as a polymer in solution showed nonspecific hydrophobic interactions between the hydrophobic moieties of the polymer and the drug (Pui et al., 2018). A study investigating the higher degree of crystallization inhibition by PAA (polyacrylic acid) compared to PVP concluded that this effect is attributed to strong specific interactions between drug and polymer as observed with NMR measurements. In a study on supersaturation stabilization of hydrocortisone acetate by HPMC authors (Raghavan et al., 2001) hypothesize that the adsorption of polymer on the crystals facilitated by hydrogen bonding is the mechanisms behind crystallization inhibition.