Terbinafine suspension formulation


Stability of terbinafine hydrochloride in an extemporaneously prepared oral suspension at 25 and 4 degrees C.

CHICAGO — A new oral formulation of the antifungal drug terbinafine significantly improved tinea capitis in children aged 4-12 years compared with griseofulvin oral suspension, based on efficacy data from 1,286 children in the largest study of the medication to date.

Terbinafine suspension formulation

Classifications

This application is a continuation of U.S. patent application Ser. No. 12-508,537, filed Jul. 23, 2009, which itself claims the benefit of U.S. Provisional Application No. 61-083,115, filed Jul. 23, 2008, U.S. Provisional Application No. 61-102,111, filed Oct. 2, 2008, U.S. Provisional Application No. 61-150,187, filed Feb. 5, 2009, and U.S. Provisional Application No. 61-168,122, filed Apr. 9, 2009. The contents of each of these applications is hereby incorporated by reference herein their entirety.

Terbinafine suspension formulation

Lamisil Oral Granules

​Before administering Lamisil Oral Granules, evaluate patients for evidence of chronic or active liver disease.

Terbinafine suspension formulation

Terbinafine in the Treatment of Trichophyton Tinea Capitis: A Randomized, Double-Blind, Parallel-Group, Duration-Finding Study

Objectives. Terbinafine has been shown to be effective in tinea capitis, using different treatment durations. However, no direct comparison of treatment duration has previously been investigated. This randomized, double-blind, parallel-group, multicenter study was designed to assess the effect of terbinafine treatment duration on the outcome of Trichophyton tinea capitis in a North American population.

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Two formulations of L-C rectal suspension were compounded and then packaged in amber polypropylene bottles. Three bottles of each formulation were stored at either 22°C or 5°C and analyzed at 11 time periods. Physical parameters such as caking, ease of resuspending, and pH were also determined at each time period. A validated stability-indicating high-performance liquid chromatography (HPLC) method was used to analyze both active ingredients.

Terbinafine suspension formulation

Abstract

There have been numerous advertisements lately promoting topical medication products for toenail fungus. Although the commercials claim effectiveness, clinical trials reveal a different outcome.

Methylcellulose vehicle is cumbersome to prepare, while SyrSpend SF is not readily available in Canada. Furthermore, conflicting information is available regarding the stability of compounded preparations of gabapentin under refrigerated conditions.

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Onychomycosis, also known as tinea unguium, is a fungal infection of the nails, having a prevalence of about 2-8% in the general population and an increased prevalence of 14 – 28% in adults over the age of 60 (Finch and Warshaw, Dermatol. Ther., 2007, 20, 31-46).

G Nine Formulations Pvt. Ltd.

This study compared the in vitro antifungal activity of TDT 067 with those of naked terbinafine (terbinafine not in Transfersome vesicles) and a commercially available terbinafine (1%) spray against dermatophytes known to cause onychomycosis, as measured by MIC and minimum fungicidal concentration (MFC).

Second-generation imidazoles, such as fluconazole and itraconazole or other new oral antifungals, may be considered if conventional topical treatments fail, particularly among immunocompromised patients. Although these drugs are effective, they are not recommended as first-line management of thrush in normal children because of limited paediatric data, potentially significant adverse effects and high costs.