A patent application has emerged that proposed what might be an improvement to the doxycycline based Oracea treatment for rosacea.
The patent seeks to create a sub-antibiotic dose formulation of doxycycline that is less susceptible to what it calls the `food effect’.
Food effect refers to food-drug interactions which lead to either a decrease or an increase of the extent of drug absorption.
The commercially available capsules of doxycycline (Oracea 40 mg capsules) for the treatment of inflammatory lesions (papules and pustules) of rosacea is a combination of immediate release (30 mg) and delayed release (10 mg) components.
As per the prescribing information, the capsules have significant food effect and thus are recommended to be taken on an empty stomach, preferably at least one hour prior to or two hours after meals.
The C.max and AUC.0-t of Oracea decrease by 45% and 22% respectively when taken along with food.
The effect of taking doxycycline with or without food can be significant.
It is possible to reduce the dose if food effect is minimized, as the same therapeutic levels may be achieved with a lesser amount of doxycycline.
Accordingly, the present invention also provides a low dose once daily tablet comprising doxycycline at sub-antibiotic dose and one or more pharmaceutically acceptable excipients, wherein the tablet exhibits a reduced food effect.
United States Patent Application 20160008379
The present invention relates to a once daily tablet comprising doxycycline at sub-antibiotic dose and one or more pharmaceutically acceptable excipients, wherein the tablet exhibits a reduced food effect. The invention further provides a method of treatment of rosacea by administering to a person in need thereof the doxycycline tablet with or without food. A process of preparing the tablet is also provided.
SUN PHARMACEUTICAL INDUSTRIES LIMITED
A once daily tablet comprising doxycycline and one or more pharmaceutically acceptable excipients, wherein the tablet exhibits a reduced food effect such that the food effect on Cmax is less than 40% compared to when the tablet is administered in a fasted state, and the food effect on AUC.sub.0-t is less than 20% compared to when the tablet is administered in a fasted state.
Sun Pharmaceutical Industries Limited is a multinational pharmaceutical company headquartered in Mumbai.
Good News for Rosacea Sufferers
If these ideas result in a product that makes it to market then this is good news for rosacea sufferers – a viable competitor to the very expensive Oracea. Rosacea sufferers seem to report that Oracea is a reasonable treatment for papules and pustules, but that it is chronically expensive if you don’t have full medical insurance. Indeed some recent research shows that the cost of Oracea is on the steady increase.