SAFER AND MORE EFFECTIVE METHODS OF TRANSMUCOSAL DELIVERY FOR RAISING BLOOD PRESSURE
The present invention provides methods of non-gastrointestinal transmucosal drug delivery that secures, sheaths, and protects vasoconstricting and or adrenergic drug from mixing with saliva and being swallowed, thereby preventing both decreased bioavailability and loss of efficacy, and ensuring restoration of proper blood perfusion. In preferred embodiments, the adrenergic drug is epinephrine and the method treats hypotension associated with anaphylaxis.
1 . A method of treating hypotension, anaphylaxis, or both in a patient, the method comprising:
dispensing, by a plunger-like applicator device, at least two dosages of at least one pharmaceutical formulation of epinephrine, the dosages in the form of a central active pharmaceutical ingredient portion surrounded by a bioadhesive layer, and the dosages including 2.5 mg to 80 mg of epinephrine in the active pharmaceutical ingredient portion and at least one pharmaceutically acceptable excipient;
holding the at least two dosages against at least one mucous membrane using the device until the dosages are secured to the at least one mucous membrane by the bioadhesive layer; and
allowing non-gastrointestinal transmucosal delivery of the at least two dosages across at least two mucous membranes simultaneously inside said patient's mouth,
wherein said method avoids at least most first-pass metabolism by the liver by preventing more than 50% of said epinephrine from being ingested, and
wherein said method is associated with at least one of greater systemic bioavailability, lower dilution, lower side effects, or a combination thereof.
2 . The method of claim 1 , including sheathing said at least two dosages with a barrier to protect from mixing with saliva outside of a zone where said at least two dosages are secured to the at least one mucous membrane so that more than 50% of said epinephrine in the active pharmaceutical ingredient portion is prevented from being swallowed.
3 . The method of claim 2 , wherein said barrier comprises a hydrophobic layer, hydrophobic surface, physical barrier, or combination thereof at least partially surrounding said at least two dosages.