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Validation of Oral/Topical Liquids and Semi-Solids
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Suppositories are lipids, either natural or synthetic, with dissolved and/or suspended API(s). The lipid must have the characteristic of “melting” at body temperature so that the drug(s) can be delivered to the patient. The final bulk is heated and filled into chilled molds; today, typically, form-fill and seal-molding machinery is used. A common rectal suppository base is cocoa butter (theobroma oil). This is a natural product and a by-product of the confection industry, and it is common to have the heated liquid filtered through “cheese cloth” as the first manufacturing step. The CPPs of this operation, such as temperature and time of heating, are important, as is the ability to be molded. CQAs are assay, uniformity, and molded shape.
Recent Developments in Nanoparticulate-Mediated Drug Delivery in Therapeutic Approaches
Published in Jyoti Ranjan Rout, Rout George Kerry, Abinash Dutta, Biotechnological Advances for Microbiology, Molecular Biology, and Nanotechnology, 2022
Janmejaya Bag, Swetapadma Sahu, Monalisa Mishra
Rectal route is an effective and localized drug delivery method for systemic treatment (Figure 18.3F). This is applicable for children, comatose, and elderly patients (Jannin et al., 2014). This method is banned in some countries due to privacy concerns. The rectal drug delivery is done in post-treatment when patients can not swallow, show regular vomiting or hesitant to parenteral administration (Batchelor, 2014). Advantages of the rectal route are (1) no enzyme in rectum, (2) easy drug delivery for the patients suffering from vomiting, pediatric, geriatric, and difficulty in swallowing (Ban and Kim, 2013; Jadhav et al., 2009), (3) easy for patients suffering from constipation, (4) protects the gastric mucosa from exposing toward irritant drugs. With modern pharmaceutics, rectal drug delivery systems increase the bioavailability and thus control the drug delivery. Various formulation, integration, and principles are applied to modify the rectal drug delivery systems (Purohit et al., 2018; Maisel et al., 2015; Basavaraj et al., 2013). Rectal administration is the shortest route to reach the targeting colon site, but sometimes the drug is not easy to access at a specific site with a specific time period. Rectal administration is sometimes uncomfortable to the patients and may be less effective. The drug delivery via rectal administration may be via foam, suspension, solution, and suppository. The corticosteroid like prednisolone is administrated via rectum for the ulcerative colitis treatment. However, this drug is absorbed by the large bowel due to mainly its topical applications. The amount and the concentration of drugs reaching the colon depend upon the formulation factor, retention time, and efficiency of drug release (Shendge and Sayyad, 2013; Watts and Lllum, 1997). Polymers that are pH sensitive can be coated to drugs and help in targeting the colon (Gupta et al., 2001),
Composition of Proprietary Products Approved in the United States
Published in Sarfaraz K. Niazi, Handbook of Pharmaceutical Manufacturing Formulations, Third Edition, 2019
Phenergan. Each tablet of Phenergan contains 12.5, 25, or 50 mg promethazine HCl. The inactive ingredients present are lactose, magnesium stearate, and methylcellulose. Each dosage strength also contains the following: 12.5 mg—FD&C Yellow No. 6 and saccharin sodium; 25 mg—saccharin sodium; 50 mg—FD&C Red No. 40. Each rectal suppository of Phenergan contains 12.5, 25, or 50 mg promethazine HCl with ascorbyl palmitate, silicon dioxide, white wax, and cocoa butter.
Evaluation of the Macy Catheter®: a rectal catheter for rapid medication and fluid administration
Published in Expert Review of Medical Devices, 2018
Kim Marie C. Macygin, Erik Kulstad, Robert K. Mokszycki, Morgan Goldsmith
Similar to acute care, the preferred choice for medication administration in the post-acute setting is PO. However, when the oral route is not an option due to patient condition, alternative routes of medication administration must be considered. Alternative routes of medication administration for the post-acute patient when the oral route fails include SL, rectal suppository or microenema, SQ, intravenous (IV), transdermal, epidural, and intrathecal [3]. These alternatives pose certain challenges due to the coordination of supplies, nursing time, and care required to maintain them. For example, when a physician order is obtained for an IV in the home, there is often a delay in delivering the required supplies and medications needed for IV access, placement, and medication administration [3]. Moreover, skilled nursing facilities or long-term care facilities may not be staffed or equipped to care for a patient requiring continuous IV treatment [3].