Topical corticosteroid formulations: bioequivalence assessment and guidelines for appropriate use

被引:0
作者
Demana, P. H. [1 ]
机构
[1] Univ Limpopo, Dept Pharm, Fac Hlth Sci, Turfloop Campus, Limpopo, South Africa
关键词
topical corticosteroids; formulation; bioequivalence; registration; clinical effect;
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
There is growth in the generic topical corticosteroid market in South Africa. Therefore, vehicle formulation and more importantly the efficacy of the product and its associated safety have become the primary issue of concern, not only for pharmaceutical manufacturers, but also for health professionals. This is particularly important for medical practitioners and pharmacists who need to prescribe or recommend the best formulation for the clinical benefit of patients. This review endeavours to provide general guidelines on the use of topical corticosteroid formulations. The background on bioequivalence assessment and registration of this type of product in South Africa is provided. This is followed by a focus on vehicle selection and a comparison of the relative potency of various corticosteroids so that appropriate therapeutic preparations may be selected by health professionals. (C) Medpharm
引用
收藏
页码:26 / 31
页数:5
相关论文
共 50 条
[41]   Bioequivalence assessment of two different tablet formulations of diltiazem after single and repeated doses in healthy subjects [J].
Loffreda, A ;
Matera, MG ;
Vacca, C ;
Motola, G ;
De Santis, D ;
Ruggiero, A ;
Russo, F ;
Fici, F ;
Cantoni, V ;
Lampa, E ;
Rossi, F .
CURRENT MEDICAL RESEARCH AND OPINION, 1999, 15 (01) :53-61
[42]   Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations [J].
Ethan M. Stier ;
Barbara M. Davit ;
Parthapratim Chandaroy ;
Mei-Ling Chen ;
Jeanne Fourie-Zirkelbach ;
Andre Jackson ;
Stephanie Kim ;
Robert Lionberger ;
Mehul Mehta ;
Ramana S. Uppoor ;
Yaning Wang ;
Lawrence Yu ;
Dale P. Conner .
The AAPS Journal, 2012, 14 :925-926
[43]   Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations [J].
Stier, Ethan M. ;
Davit, Barbara M. ;
Chandaroy, Parthapratim ;
Chen, Mei-Ling ;
Fourie-Zirkelbach, Jeanne ;
Jackson, Andre ;
Kim, Stephanie ;
Lionberger, Robert ;
Mehta, Mehul ;
Uppoor, Ramana S. ;
Wang, Yaning ;
Yu, Lawrence ;
Conner, Dale P. .
AAPS JOURNAL, 2012, 14 (04) :925-926
[44]   Methylphenidate Multiphasic Release Tablet: Bioequivalence Assessment between Two Formulations Administered under Fasting and Fed Conditions [J].
Davanco, Marcelo Gomes ;
Meulman, Jessica ;
da Silva, Thalita Martins ;
Costa, Fernando ;
Bellorio, Karini Bruno ;
Mundim, Iram Moreira ;
Sampaio, Ana Carolina Costa ;
de Souza Teixeira, Leonardo ;
Vespasiano, Celso Francisco Pimentel .
PHARMACEUTICS, 2023, 15 (06)
[45]   Assessment of the impact of partial area under the curve in a bioavailability/bioequivalence study on generic prolonged-release formulations [J].
Soares, Kelen Carine Costa ;
Chiann, Chang ;
Storpirtis, Silvia .
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2022, 171
[46]   DOSE PROPORTIONALITY OF STAVUDINE IN HIV-SEROPOSITIVE ASYMPTOMATIC SUBJECTS - APPLICATION TO BIOEQUIVALENCE ASSESSMENT OF VARIOUS CAPSULE FORMULATIONS [J].
KAUL, S ;
MUMMANENI, V ;
BARBHAIYA, RH .
BIOPHARMACEUTICS & DRUG DISPOSITION, 1995, 16 (02) :125-136
[47]   The human skin blanching assay for in vivo topical corticosteroid assessment .1. Reproducibility of the assay [J].
Haigh, JM ;
Meyer, E ;
Smith, EW ;
Kanfer, I .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1997, 152 (02) :179-183
[48]   Prevalence of Topical Corticosteroid Use without Prescription in Saudi Arabia: A Cross-sectional Study [J].
Al-Aojan, Shaikah ;
Al-Marzoug, Alanoud ;
Alaujan, Abdulrahman ;
Abanmi, Samiah ;
AlJasser, Mohammed, I .
JOURNAL OF DERMATOLOGY & DERMATOLOGIC SURGERY-JDDS, 2021, 25 (02) :76-79
[49]   Pediatric iatrogenic Cushing's syndrome: a series of seven cases induced by topical corticosteroid use [J].
Kilci, Fatih ;
Sarikaya, Emre .
JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM, 2025, 38 (08) :863-867
[50]   Assessment of bioequivalence of rifampicin, isoniazid and pyrazinamide in a four drug fixed dose combination with separate formulations at the same dose levels [J].
Agrawal, S ;
Kaur, KJ ;
Singh, I ;
Bhade, SR ;
Kaul, CL ;
Panchagnula, R .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2002, 233 (1-2) :169-177