Protein drug delivery: current dosage form profile and formulation strategies

被引:25
|
作者
Geraldes, Danilo Costa [1 ,2 ]
Beraldo-de-Araujo, Viviane Lucia [1 ,2 ]
Pichihua Pardo, Boris Odelion [3 ]
Pessoa Junior, Adalberto [4 ]
Stephano, Marco Antonio [4 ]
de Oliveira-Nascimento, Laura [1 ,2 ]
机构
[1] Univ Estadual Campinas, Fac Pharmaceut Sci, Rua Candido Portinari 200, BR-13083871 Campinas, SP, Brazil
[2] Univ Estadual Campinas, Biol Inst, Biochem & Tissue Biol Dept, Campinas, SP, Brazil
[3] Natl Univ San Marcos, Fac Pharm & Biochem, Lima, Peru
[4] Univ Sao Paulo, Fac Pharmaceut Sci, Sao Paulo, SP, Brazil
关键词
Protein drug; excipient; dosage form; freeze-drying; protein stability; IN-VIVO PHARMACOKINETICS; HUMAN GROWTH-HORMONE; ORAL DELIVERY; MONOCLONAL-ANTIBODY; TOPICAL DELIVERY; NONCOVALENT PEGYLATION; INTRACELLULAR DELIVERY; ARGININE GLUTAMATE; CONTROLLED-RELEASE; MOLECULAR-WEIGHT;
D O I
10.1080/1061186X.2019.1669043
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Protein drugs present specific challenges to the maintenance of long-term stability, which can be accomplished by altering parameters of obtention, purification, molecule structure and formulation. As we believe, commercial formulations are undervalued; therefore, this review focuses on screening, categorising and discussing all formulations of protein drugs approved and not withdrawn by regulatory agencies from United States, Canada and Europe until mid-2018. Peptides (<50 amino acids) were not included to allow a more precise evaluation of choices for larger molecules. We extracted data from the DrugBank database, cross-checked it with the FDA purple book and supplemented it with patient information leaflets and papers. We further classified and discussed the entries according to protein function, drug delivery, route of administration and types of excipient (freeze-dried forms). In addition, alternative choices of excipients were discussed. Experimental work included here relates to targeting strategies with verified pharmacokinetics or in vivo effectiveness to identify physiologically relevant options. Although no single rule can be set for efficient protein formulation, our data help to better understand and optimise the choice for excipients and pharmaceutical dosage forms. For more information, see the Supplemental Data.
引用
收藏
页码:339 / 355
页数:17
相关论文
共 50 条
  • [41] Current and emerging formulation strategies for the effective transdermal delivery of HIV inhibitors
    Ham, Anthony S.
    Buckheit, Robert W., Jr.
    THERAPEUTIC DELIVERY, 2015, 6 (02) : 217 - 229
  • [42] Solid Dosage Forms of Biopharmaceuticals in Drug Delivery Systems Using Sustainable Strategies
    Costa, Clarinda
    Casimiro, Teresa
    Corvo, Maria Luisa
    Aguiar-Ricardo, Ana
    MOLECULES, 2021, 26 (24):
  • [43] Advances in formulation and manufacturing strategies for the delivery of therapeutic proteins and peptides in orally disintegrating dosage forms
    Bashir, Shazia
    Fitaihi, Rawan
    Abdelhakim, Hend E.
    EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2023, 182
  • [44] In vitro dissolution profile comparison of an anti-migraine combinational drug in dosage form
    Hiremath, Vijay Basayya
    Kaliaperumal, Krishna
    Bhojraj, Suresh
    Nanjan, Mulla Joghee
    CHINESE JOURNAL OF CHROMATOGRAPHY, 2010, 28 (01) : 93 - 99
  • [45] Designing of a phytosome dosage form with Tecomella undulata as a novel drug delivery for better utilization
    Nagpal, Navneet
    Arora, Manisha
    Swami, Gaurav
    Rageeb
    Kapoor, Reni
    PAKISTAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2016, 29 (04) : 1231 - 1235
  • [46] Design and development of a topical dosage form for the convenient delivery of electrospun drug loaded nanofibers
    Karthikeyan, K.
    Sowjanya, Rajeswari Satya
    Yugandhar, Aditya D. V.
    Gopinath, S.
    Korrapati, Purna Sai
    RSC ADVANCES, 2015, 5 (65) : 52420 - 52426
  • [47] FORMULATION AND DOSAGE FORM DESIGN IN DRUG-INDUCED TOPICAL IRRITATION OF THE GASTROINTESTINAL-TRACT
    FARA, JW
    MYRBACK, RE
    PHARMACEUTICAL RESEARCH, 1990, 7 (06) : 616 - 620
  • [48] LIPOSOMES - A SELECTIVE DRUG DELIVERY SYSTEM FOR THE TOPICAL ROUTE OF ADMINISTRATION - GEL DOSAGE FORM
    MEZEI, M
    GULASEKHARAM, V
    JOURNAL OF PHARMACY AND PHARMACOLOGY, 1982, 34 (07) : 473 - 474
  • [49] Multiparticulate formulation approach to colon specific drug delivery: Current perspectives
    Asghar, Laila Fatima Ali
    Chandran, Sajeev
    JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, 2006, 9 (03): : 327 - 338
  • [50] Osmotic capsules: A universal oral, controlled-release drug delivery dosage form
    Waterman, Kenneth C.
    Goeken, G. Scott
    Konagurthu, Sanjay
    Likar, Michael D.
    MacDonald, Bruce C.
    Mahajan, Nidhi
    Swaminathan, Vidya
    JOURNAL OF CONTROLLED RELEASE, 2011, 152 (02) : 264 - 269