Results 21 to 30 of about 741 (144)

Drug Product Development of Lipid Nanoparticle-Based mRNA Therapeutics and Vaccines. [PDF]

Wiley Interdiscip Rev Nanomed Nanobiotechnol
Overview of the development path from an mRNA–lipid nanoparticle (LNP) concept to a licensed drug product, covering LNP design, manufacturing process development, formulation, and analytical characterization. ABSTRACT Lipid nanoparticles (LNP) are currently the most relevant non‐viral delivery systems for mRNA and occasionally for smaller nucleic acids
Kersten G, Cerasoli E, Kerwin B, Merkel OM, Hawe A.   +4 more
europepmc   +2 more sources

Soft Gelatine Capsules- Critical Quality Attributes of Chosen Excipients and Capsules Parameters Following the Quality by Design Concept [PDF]

Acta Poloniae Pharmaceutica, 2023
Soft gel capsules are a common form of medicine and food supplements. Quality, productivity and manufacturing time is crucial for producers during their development and industrial operations.
Barbara Owczarek, Edyta Łukowska-Chojnacka   +1 more
doaj   +1 more source

Впровадження підходу Quality by Design для розробки складу та технології виробництва ін’єкційного препарату для внутрішньосуглобового введення [PDF]

, 2021
Aim. To implement the Quality by Design (QbD) approach in order to develop the composition and the manufacturing technology of injectable hyaluronate sodium (HS) in combination with chondroitin sulfate (CS) for intra-articularintroduction.
Palchevska, T., Nebylytsia, K., Saliy, O., Los, O.   +3 more
core   +1 more source

Optimizing clarification processes in biopharmaceutical manufacturing through quality by design: Strategies, implications, and future prospects. [PDF]

Biotechnol Prog
Abstract Biopharmaceutical manufacturing processes in which the product of interest is extracellularly expressed typically employ a clarification step following cell culture or fermentation. During clarification, crude cell culture fluid or fermentation broth is processed to remove insoluble solids, cells, debris, and other particulates, with the ...
Yeop KW, Nam HJ, Shim CJ, Yang SM, Kim HW, Park CI, Banerjee S, Mok Y.   +7 more
europepmc   +2 more sources

Comprehensive stability-indicating method development of Avanafil Phosphodiesterase type 5 inhibitor using advanced Quality-by-Design approach

Journal of Analytical Science and Technology, 2020
Avanafil (AV) is the phosphodiesterase (PDE) type 5 inhibitor drug used in erectile dysfunction, having pyrrolidine, pyrimidine, carboxamide, and chlorine as functional groups which can easily break by environmental changes and cause toxicity. Henceforth,
Mital Patel, Charmy Kothari
doaj   +1 more source

Внедрение подхода Quality by Design для разработки состава и технологии производства инъекционного препарата для внутрисуставного введения [PDF]

, 2021
Мета роботи – dпровадження підходу Quality by Design (QbD) для розробки складу та технології виробництва ін’єкційного препарату гіалуронату натрію (ГН) у поєднанні з хондроїтину сульфатом (ХС) для внутрішньосуглобового введення.
Пальчевська, Т. А., Лось, О. В., Небилиця, К. В., Салій, О. О.   +3 more
core   +1 more source

Quality by Design Guided Development of Polymeric Nanospheres of Terbinafine Hydrochloride for Topical Treatment of Onychomycosis Using a Nano-Gel Formulation

Pharmaceutics, 2022
Superficial fungal diseases of the skin and nails are an increasingly common occurrence globally, requiring effective topical treatment to avoid systemic adverse effects.
Vinam Puri, Anna Froelich, Parinbhai Shah, Shernelle Pringle, Kevin Chen, Bozena Michniak-Kohn   +5 more
doaj   +1 more source

Обґрунтування цільового профілю якості та оцінювання ризиків для розробки комбінованого препарату для ін’єкцій [PDF]

, 2022
Aim. To substantiate the target quality profile for planning the development of a combined drug for injection based on sodium hyaluronate (SH) and dihydroquercetin (DHQ) with an expanded spectrum of the specific activity, as well as to determine the risk
Semenova, K. M., Almakaieva, L.
core   +1 more source

Deduction of the operable design space of RP-HPLC technique for the simultaneous estimation of metformin, pioglitazone, and glimepiride

Scientific Reports, 2023
A reversed-phase RP-HPLC method was developed for the simultaneous determination of metformin hydrochloride (MET), pioglitazone (PIO), and glimepiride (GLM) in their combined dosage forms and spiked human plasma.
Aya A. Marie, Sherin F. Hammad, Mohamed M. Salim, Mahmoud M. Elkhodary, Amira H. Kamal   +4 more
doaj   +1 more source

Design and characterization of combinational domperidone-famotidine floating drug delivery system - In vitro and in vivo studies

Ars Pharmaceutica, 2021
Introduction: The drawbacks assosiated with oral administration of drugscan be controlled or minimized by gastro retentive formulations that remain buoyant within the stomach for an extended time by providing prolonged gastric retention and releasethe ...
Mounika Chidurala, Raveendra Reddy
doaj   +1 more source