Development pharmaceutics of microbicide formulations. Part II: formulation, evaluation, and challenges.
In recent years, AIDS and sexually transmitted diseases (STDs) have become a burgeoning problem and are spreading at an alarming rate. Microbicides are being developed as a new therapeutic category for prevention of transmission of sexually transmitted infections (STIs) and HIV. Many of the microbic...
| Publicado en: | AIDS Patient Care & STDs Vol. 17; no. 8; pp. 377 - 400 |
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| Autores principales: | , , , , , , |
| Formato: | review tables/charts Journal Article |
| Publicado: |
Mary Ann Liebert, Inc.
Aug2003
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106726263&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106726263 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10872914 33C jtl: AIDS Patient Care & STDs issn: 10872914 maglogo: N pubinfo: dt: Aug2003 vid: 17 iid: 8 pid: 1365 pub: Mary Ann Liebert, Inc. place: New Rochelle, New York artinfo: ui: 106726263 106726263 2004059164 10.1089/108729103322277402 NLM13678540 106726263 ppf: 377 ppct: 23 formats: tig: atl: Development pharmaceutics of microbicide formulations. Part II: formulation, evaluation, and challenges. aug: au: Garg S Tambwekar KR Vermani K Kandarapu R Garg A Waller DP Zaneveld LJD affil: Dept of Pharmaceutics, National Institute of Pharmaceutical Education and Research, Sector 67, SAS Nagar, Punjab 160062, India; gargsanjay@yahoo.com sug: subj: Administration, Intravaginal Antiinfective Agents Administration and Dosage Chemistry, Pharmaceutical Dosage Forms Product Development Sexually Transmitted Diseases Prevention and Control Administration, Rectal Antiinfective Agents Pharmacodynamics Antiinfective Agents Pharmacokinetics Creams Drug Packaging Drug Stability Drug Storage Emulsions Funding Source Gels HIV Infections Ointments Pessaries Product Evaluation Solubility Suppositories Suspensions Tablets ab: In recent years, AIDS and sexually transmitted diseases (STDs) have become a burgeoning problem and are spreading at an alarming rate. Microbicides are being developed as a new therapeutic category for prevention of transmission of sexually transmitted infections (STIs) and HIV. Many of the microbicide formulations (MF) may fail to elicit a protective response either because of a lack of efficacy or inadequate formulation. Manufacturing a stable, efficacious, safe, and optimal product is the main objective of formulation development programs. Preformulation parameters (PP), as discussed in Part I of this series, influence formulation development significantly and should be considered carefully before designing a formulation strategy. Initially, based on PP and market research, a target product profile (TPP) is generated, which defines product attributes that can be normally classified as 'essential' and 'desirable.' A complex and dynamic process begins thereafter that takes into consideration myriad factors starting from selection of delivery system, selection of excipients, compatibility study, prototype composition, selection of process and optimization, stability testing, scale up, manufacturing under good manufacturing practices (GMP), and packaging development. Prototype formulations are evaluated for several performance characteristics (e.g., dispersion behavior, bioadhesion, retention, spreading, rheology). These compositions are also subjected to biologic evaluation by various in vitro and in vivo models. Such a well-planned, well-coordinated, and well-implemented formulation development program not only accelerates overall development but also minimizes failures in subsequent clinical development studies. The objective of this review is to highlight the importance of formulation science, outline the steps involved in this process, and explore how these can be exploited for achieving optimal MF. pubtype: Academic Journal doctype: review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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