Topical drug classification

Buhse, Lucinda F.; Kolinski, Richard E.; Westenberger, Benjamin J.; Wokovich, Anna M.; Spencer, John; Chen, Chi Wan; Turujman, Saleh A.; Gautam-Basak, Mamta; Kang, Gil J.; Kibbe, Arthur H.; Heintzelman, Brian; Wolfgang, Eric A.

doi:10.1016/j.ijpharm.2005.01.032

Cited by 82 publications

(62 citation statements)

References 2 publications

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“…vary and are ill-defined and imprecise in some cases. Based on rheological behavior, water and volatiles, composition, and thermal behavior, Buhse et al [1] devised new definitions and a system for determination of the appropriate nomenclature for a topical dosage form. Osborne [2] further summarized the topical drug product classification system and discussed the importance of accurately labeling a topical dosage form.…”

Section: Formulation Design Of Generic Topical Drug Productsmentioning

confidence: 99%

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Chang

Raw

Lionberger

et al. 2012

AAPS J

232

164

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This review presents considerations which can be employed during the development of a semi-solid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production. This encompasses the concept of reverse-engineering to copy the RLD as a strategy during product development to ensure qualitative (Q1) and quantitative (Q2) formulation similarity, as well as similarity in formulation microstructure (Q3). The concept of utilizing in vitro skin permeation studies as a tool to justify formulation differences between the test generic product and the RLD to ensure a successful pharmacodynamic or clinical endpoint bioequivalence study is discussed. The review concludes with a discussion on drug product evaluation and quality tests as well as in vivo bioequivalence studies.

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Section: Formulation Design Of Generic Topical Drug Productsmentioning

confidence: 99%

Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Chang

Raw

Lionberger

et al. 2012

AAPS J

232

164

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“…Several studies have already been carried out on the release and skin permeation of drugs from topical formulations such as ointments and creams. [1][2][3][4] We have studied the effect of sebum or relative skin lipids on the release and skin permeation of drugs from topical formulations. When a pressure sensitive adhesive (PSA) patch containing lidocaine was applied to hairless rat skin, the drug crystal was dissolved in the PSA by the sebum or skin lipids that penetrated from the skin surface to the PSA matrix.…”

mentioning

confidence: 99%

Effect of Sebum and Ointment Rubbing on the Skin Permeation of Triamcinolone Acetonide from White Petrolatum Ointment

Ishii

Todo

Sugibayashi

2010

Biological & Pharmaceutical Bulletin

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It is very important to clarify the partition and diffusion of drugs into and through the skin barrier for effective therapy when using topical drug formulations. Several studies have already been carried out on the release and skin permeation of drugs from topical formulations such as ointments and creams. [1][2][3][4] We have studied the effect of sebum or relative skin lipids on the release and skin permeation of drugs from topical formulations. When a pressure sensitive adhesive (PSA) patch containing lidocaine was applied to hairless rat skin, the drug crystal was dissolved in the PSA by the sebum or skin lipids that penetrated from the skin surface to the PSA matrix.5) In addition, release and skin permeation of a hydrophilic drug were increased from white petrolatum by addition of sebum or skin lipids. 6) Cholesterol, cholesteryl oleate and ceramide were detected in a white petrolatum which was pre-applied to hairless rat skin. 6) However, the effect of sebum or skin lipids has not yet been determined on the skin permeation of lipophilic drugs.Semisolid formulations such as ointments and creams are applied to skin, sometimes by rubbing on the skin surface. This is a key difference of semisolid formulations compared to skin adhesive topical formulations like patches and plasters. Rubbing ointments on skin may increase the skin permeation of entrapped drugs in ointments. However, quantitative studies have not yet been done on the ointment-rubbing effect on the skin permeation of drugs.In the present study, a broadly used steroidal drug, triamcinolone acetonide (TA) (MW; 434.5, mp; 290°C, log P; 2.53, solubility in water at 25°C; 22.05Ϯ0.05 mg/ml, and solubility parameter; 9.45 (cal/cm 3 ) 1/2 ) was selected as a model lipophilic drug, and white petrolatum was used as an ointment base.7) The effect of sebum or skin lipids was determined on the dissolution and skin permeation of TA in and from white petrolatum, respectively. The rubbing effect of the ointment on the skin surface was also measured on the skin permeation and skin concentration of TA. MATERIALS AND METHODSMaterials and Experimental Animals TA powder (mean diameter; 5 mm) was purchased from Wako Pure Chemical Industries, Ltd. (Osaka, Japan). White petrolatum was purchased from Kosakai Pharmaceutical, Ltd. (Tokyo, Japan). Other chemicals and solvents were of reagent grade or HPLC grade and used without further purification. Male hairless rats (WBM/ILA-Ht, 8-9 weeks-old, body weight: 230-260 g) were obtained from the Life Science Research Center, Josai University (Sakado, Saitama, Japan) or Ishikawa Experimental Animals (Fukaya, Saitama, Japan). The animal feeding and experiments were conducted according to the ethical committee in Josai University.Preparation of White Petrolatum Ointment Containing Triamcinolone Acetonide White petrolatum ointments (original ointment) of TA at concentrations of 10-50 mg TA/g (1.0-5.0%) were prepared by thoroughly mixing with white petrolatum to prepare a "TA original ointment." In order to evaluate the effect of s...

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“…TC are classified in two different ways by American and British National Formulary classification systems [20][21]. The American classification system includes seven potency groups while the British National Formulary contains four groups.…”

Section: Classification Of Tcmentioning

confidence: 99%

“…Vehicles should allow adequate release of the active compound, spread easily and be aesthetically pleasant [21]. Some important rules should be considered when choosing a vehicle; the solubility, release rate and stability of the therapeutic agent in the vehicle, the ability of the vehicle to hydrate the SC, the physical and chemical interactions of the vehicle with the skin and active molecule and also the phase, localization and extent of disease [22].…”

Section: Formulations Of Tcmentioning

confidence: 99%