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Quality by Design Considerations for Drop-on-Demand Point-of-Care Pharmaceutical Manufacturing of Precision Medicine.

التفاصيل البيبلوغرافية
العنوان: Quality by Design Considerations for Drop-on-Demand Point-of-Care Pharmaceutical Manufacturing of Precision Medicine.
المؤلفون: Forbes TP; Materials Measurement Science Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States., Gillen JG; Materials Measurement Science Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States., Feeney W; Materials Measurement Science Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States., Ho J; Materials Measurement Science Division, National Institute of Standards and Technology, Gaithersburg, Maryland 20899, United States.
المصدر: Molecular pharmaceutics [Mol Pharm] 2024 Jul 01; Vol. 21 (7), pp. 3268-3280. Date of Electronic Publication: 2024 Apr 25.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: American Chemical Society Country of Publication: United States NLM ID: 101197791 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1543-8392 (Electronic) Linking ISSN: 15438384 NLM ISO Abbreviation: Mol Pharm Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Washington, DC : American Chemical Society, c2004-
مواضيع طبية MeSH: Precision Medicine*/methods , Point-of-Care Systems* , Quality Control* , Technology, Pharmaceutical*/methods, Humans ; Printing, Three-Dimensional ; Pharmaceutical Preparations/chemistry
مستخلص: Distributed and point-of-care (POC) manufacturing facilities enable an agile pharmaceutical production paradigm that can respond to localized needs, providing personalized and precision medicine. These capabilities are critical for narrow therapeutic index drugs and pediatric or geriatric dosing, among other specialized needs. Advanced additive manufacturing, three-dimensional (3D) printing, and drop-on-demand (DoD) dispensing technologies have begun to expand into pharmaceutical production. We employed a quality by design (QbD) approach to identify critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs) of a POC pharmaceutical manufacturing paradigm. This theoretical framework encompasses the production of active pharmaceutical ingredient (API) "inks" at a centralized facility, which are distributed to POC sites for DoD dispensing into/onto delivery vehicles ( e.g. , orodispersible films, capsules, single liquid dose vials). Focusing on the POC dispensing/dosing processes, QbD considerations and cause-and-effect analyses identified the dispensed API quantity and solid-state form (CQAs), as well as the nozzle diameter, system pressure channel, and number of drops dispensed (CPPs) for detailed investigation. Final assay quantification and content uniformity CQAs were measured from demonstrative levothyroxine sodium single-dose liquid vials of glycerin/water, meeting the standard acceptance values. Each POC facility is unlikely to maintain full quality control laboratory capabilities, requiring the development of appropriate atline or inline methods to ensure quality control. We developed control strategies, including atline ultraviolet-visible (UV-vis) verification of the API ink prior to dispensing, inline drop counting during dispensing, intermediate atline-dispensed volume checks, and offline batch confirmation by liquid chromatography-tandem mass spectrometry (LC-MS/MS) following production.
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معلومات مُعتمدة: 9999-NIST United States ImNIST Intramural NIST DOC
فهرسة مساهمة: Keywords: drop-on-demand; drug delivery; manufacturing; narrow therapeutic index; personalized medicine; pharmaceutics; point-of-care
المشرفين على المادة: 0 (Pharmaceutical Preparations)
تواريخ الأحداث: Date Created: 20240425 Date Completed: 20240701 Latest Revision: 20240723
رمز التحديث: 20240723
مُعرف محوري في PubMed: PMC11262155
DOI: 10.1021/acs.molpharmaceut.4c00032
PMID: 38661480
قاعدة البيانات: MEDLINE
الوصف
تدمد:1543-8392
DOI:10.1021/acs.molpharmaceut.4c00032