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Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein Formulations.

Autor: Pegues MA; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Szczepanek K; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Sheikh F; Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Thacker SG; Laboratory of Immunology, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Aryal B; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Ghorab MK; Policy Development and Evaluation Branch 1, Division of Regulations, Guidance and Standards, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Wolfgang S; Cosmetics Regulatory Activities Branch, Cosmetics Division, Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition, College Park, MD, 20740, USA., Donnelly RP; Division of Biotechnology Research and Review II, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Verthelyi D; Laboratory of Immunology, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA., Rao VA; Laboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Silver Spring, MD, 20993, USA. ashutosh.rao@fda.hhs.gov.

Publikováno v: Pharmaceutical research [Pharm Res] 2021 Nov; Vol. 38 (11), pp. 1961-1975. Date of Electronic Publication: 2021 Nov 29.

Moisture-Mediated Interactions Between Amorphous Maltodextrins and Crystalline Fructose.

Autor: Thorat A; Dept. of Food Science, Purdue Univ., 745 Agriculture Mall Drive, West Lafayette, IN, 47907, U.S.A.; Dept. of Industrial and Physical Pharmacy, Purdue Univ., 575 Stadium Mall Drive, West Lafayette, IN, 47907, U.S.A., Marrs KN; Dept. of Food Science, Purdue Univ., 745 Agriculture Mall Drive, West Lafayette, IN, 47907, U.S.A., Ghorab MK; Dept. of Food Science, Purdue Univ., 745 Agriculture Mall Drive, West Lafayette, IN, 47907, U.S.A.; Dept. of Industrial and Physical Pharmacy, Purdue Univ., 575 Stadium Mall Drive, West Lafayette, IN, 47907, U.S.A., Meunier V; Nestlé Research Center, Vers-chez-les-Blanc, Route du Jorat, 1005, Lausanne, Switzerland., Forny L; Nestlé Research Center, Vers-chez-les-Blanc, Route du Jorat, 1005, Lausanne, Switzerland., Taylor LS; Dept. of Industrial and Physical Pharmacy, Purdue Univ., 575 Stadium Mall Drive, West Lafayette, IN, 47907, U.S.A., Mauer LJ; Dept. of Food Science, Purdue Univ., 745 Agriculture Mall Drive, West Lafayette, IN, 47907, U.S.A.

Publikováno v: Journal of food science [J Food Sci] 2017 May; Vol. 82 (5), pp. 1142-1156. Date of Electronic Publication: 2017 Mar 20.

Water-solid interactions in amorphous maltodextrin-crystalline sucrose binary mixtures.

Autor: Ghorab MK; Department of Industrial and Physical Pharmacy ., Toth SJ, Simpson GJ, Mauer LJ, Taylor LS

Publikováno v: Pharmaceutical development and technology [Pharm Dev Technol] 2014 Mar; Vol. 19 (2), pp. 247-56. Date of Electronic Publication: 2013 Mar 12.

Formulation, characterization, and clinical evaluation of microemulsion containing clotrimazole for topical delivery.

Autor: Hashem FM; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Helwan University, Cairo, Egypt., Shaker DS, Ghorab MK, Nasr M, Ismail A

Publikováno v: AAPS PharmSciTech [AAPS PharmSciTech] 2011 Sep; Vol. 12 (3), pp. 879-86. Date of Electronic Publication: 2011 Jul 02.