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26 Pharmaceutical Technology ® Quality and Regulatory Sourcebook March eBook 2023 PharmTech.com Manufacturing Somet i mes, d r ug compou nd i ng i s per for med in case the ready-to-use formulation of a dr ug is needed but not available commercially (especially in [the] case of pediatrics where the dosing to be done [is] based on body weight), and the drug substance is not stable in the final dosage form to be administered to the patient. Compounded drugs are currently being adminis- tered through various routes such as oral, nasogas- tric, intravenous, vaginal, etc. Ready-to-use formulations of drugs (single dose or multiple dose) such as capsules, tablets, syrups, sus- pensions, and simple solutions are manufactured with a defined and established set of procedures to make them available to the user/patient directly. Schniepp/Lynn (RCA): The processes used to manu- facture compounded drugs differ from standard phar- maceutical manufacturing processes because they are typically manual operations as opposed to the auto- mated processes used in traditional pharmaceutical manufacturing. Manual processes are slower and yield less product per batch. The process used by compound- ers is dependent on human manipulation and their ad- herence to strict manual aseptic processing technique. PharmTech: What kinds of equipment are involved in the manufacture of compounded drugs? Schniepp/Lynn (RCA): The manufacturing pro- cesses involved in compounded drugs are manual a nd t y pica l ly ut i l i ze laborator y hood s, pipet tes, hoses, inject ion need les, a nd ca rboys. W hen t he compounder is producing a sterile injectable prod- uc t, t he stopper i ng of t he v ia l w i l l ta ke place i n t he laborator y hood where t he produc t is bei ng compounded. Car ts and trays are also utilized to transport materials to the laboratory hood where it will be formulated. Singnurkar (Syngene): Depending on the route of administration, various equipment ranging from applicators, dispensers, balances, mixing, milling [and] filling, capsule filling equipment, pill counter, conventiona l oven, [and] auto clave are t y pica l ly available in a compounding firm. In general, the equipment and utensils used for compounding sha l l have appropriate design and c a p a c i t y a c c o r d i n g t o d o s a g e f o r m s a n d t h e qua nt it ies compou nded. T he su r face of t he con- tact component should be neither reactive nor ad- ditive so as not to af fect or alter the purit y of the compounded preparations. Automated and other types of equipment used in compounding or testing of compounded prepara- tions shall be routinely inspected, calibrated as nec- essary, and checked to ensure proper performance. Extra care should be practiced when cleaning equip- ment used i n compound i ng prepa rat ion requi re specia l precaut ion s (e.g., hor mones, a nt ibiot ics, CALL FOR PAPERS Pharmaceutical Technology and Pharmaceutical Technology Europe cover all aspects of pharmaceutical drug development and manufacturing, including formulation development, process development and manufacturing of active pharmaceutical ingredients (both small molecule and large molecules) and finished drug-products (solid dosage, semisolid, liquids, parenteral drugs and topical drugs), drug-delivery technologies, analytical methods development, analytical testing, quality assurance/ quality control, validation and advances in pharmaceutical equipment, machinery, instrumentation, facility design and plant operations. We are currently seeking novel research articles for our peer- reviewed journal as well as manuscripts for our special issues. For peer-reviewed papers, members of the Editorial Advisory Board of Pharmaceutical Technology and Pharmaceutical Technology Europe and other industry experts review manuscripts on technical and regulatory topics. The review process is double-blind. Manuscripts are reviewed on a rolling basis. Our single-themed issues, which include literature reviews and tutorials, address excipients and ingredients, analytical testing, outsourcing, solid dosage and more. Please visit our website, w w w.PharmTech.com/ view/pharmaceutical- technolog y-submission-guidelines-and-editorial-calendars, to view our full Author Guidelines. Manuscript s may be sent to Managing Editor Susan Haigney at shaigney@mjhlifesciences.com. C A L L FOR PAP ERS C A L L F O R P A P E R S CALL FOR PAPERS