Taclonex Topical Suspension
Taclonex® Topical Suspension should not be used with occlusive dressings unless directed by a physician. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.
Choice of base formulation
These are formed by one or more substances that are in solid state suspended in a liquid medium. To be a suspension and not a solution, the solid particles can not be soluble in the liquid medium.
Also, formulators should be certain that the excipients and quantity used in the drug product are in IIG list with the same route of administration and no more than the amount listed in the IIG. In case a novel excipient is essential to achieve the desired physicochemical properties and performance characteristics for the drug product, appropriate toxicological and pharmacological data need to be generated to support its use in drug product formulation. In general, pharmaceutical formulators avoid this costly approach.
Oral Solutions and Suspensions (8-94)
Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s).
Topical drug dosage forms for eye conditions
Pharmacists managing localised eye problems should be aware of the dosage froms that can be administered topically to the eye — solutions, suspensions and ointments — and their advantages, disadvantages, and considerations for use.
Generic topical drug products considered to be new drugs are subject to the requirements of Division 8 of Part C of the Food and Drug Regulations. NDSs for these preparations are required to contain evidence of safety and efficacy under the proposed conditions of use in conformity with sections C.O8.002 and C.O8.005.1 of the Regulations.
The present invention therefore also relates to the use of these formulations for the treatment of topical infections (for example MRSA), as well as to processes for the preparation of the formulations defined herein.
Topical suspension formulations containing ciprofloxacin and dexamethasone
The dexamethasone ingredient will comprise about 0.01-0.5% and the ciprofloxacin ingredient will comprise about 0.1-0.4% of the formulations of the present invention. The preferred amounts of dexamethasone and ciprofloxacin in the formulations of the present invention are 0.1% and 0.3%, respectively.