We have evaluated the wound healing potentials of a compound at a particular concentration in ointment form in laboratory animals. Now, we are preparing different types of topical formulations (gel, ointment, spray etc) for wound healing studies on clinical wounds of domestic/livestock animals. Does it require to test each topical formulation again on laboratory animals before proceeding for study on clinical wounds?. Please, also tell me that what should be the other guidelines which I have to follow before going for study of our topical formulations on clinical wounds of livestock animals (sheep, goat, cattle etc) for the drug development process.
I think yes every formulation should be tested because excipients will be different in each formulation and may lead to increased or decreased bioavailability.
Regards
Yes, it needs to be tested, verified by scientific approach or formulas.
why? the solvents,preservatives, colorants and diluents of the product have to maintain the active ingredients's effectiveness on the final product. (e.g oils,fats, water, alcohol,chloroforms,tatrazine) will make the product stability to differ with other formulas. The stabilizers and
Yes, it should be tested individually. Drug bioavailability also depends on the type of formulation.
Yes, you have to test all because the type of formulation influence bioavailability, and this will help you established the best dosage form.
There can be unexpected differences at a variety of times and formulation levels, so yes you have to thurougly trst not just at lab conditions, but also at field conditions because there can be unexpected interactions between elements found commonplace in the areas the drugs will be used, which is where market effectiveness will truly be measured.
I think all the answers are OK. However, remember that the requirements for submission and register any animal drug for veterinary use can be differents beetween countries.
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