PHARMACEUTICAL FORMULATIONS AND SYSTEMS FOR DELIVERY OF AN ANDROGENIC AGENT AND AN AROMATASE INHIBITOR WITH SUSTAINED MULTI-PHASIC RELEASE PROFILES AND METHODS OF USE

Abstract: the present disclosure is directed formulations, delivery systems and/or methods of use that have a novel a sustained release multi-phasic concentration pattern that may be used, among other things, for reducing mammographic breast density and/or breast stiffness in warm-blooded animals. for example, the formulation may comprise: the administration of an effective amount of androgenic agent and an effective amount of an aromatase inhibitor to a subject that provides a sustained release multi-phasic concentration pattern in the blood of the subject over time as measured by serum concentration for the androgen and plasma concentration for the aromatase inhibitor and improves, amoung other things, breast tissue stabilization and/or increases of the levels of androgen receptor expression. the present disclosure is also directed to the use of an effective amount of an androgenic agent in combination with an effective amount of an aromatase inhibitor for the prophylaxis or treatment of autoimmune inflammatory mastitis (aim) in a patient in need thereof. autoimmune inflammatory mastitis includes the conditions of idiopathic inflammatory macromastia, plasma cell mastitis, granulomatous mastitis.

Inventor(s): Stephen Nigel BIRRELL

CPC Classification: A61K31/568 (PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms ; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles ; soap compositions ))

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