Pharmaceutical composition for compressed annular tablet with molded triturate tablet for both intraoral and oral administration

A process for the preparation of a pharmaceutical composition in unit dosage form as a compressed annular tablet with molded triturate tablet for both intraoral and oral administration to a patient, said pharmaceutical composition to be placed intraorally of said patient, which comprises:

• (a) as a first releasing portion, a molded triturate tablet comprising a therapeutically effective amount of at least one pharmaceutically active ingredient capable of intraoral administration;
• and
• (b) as a second releasing portion located around said first portion, a therapeutically effective amount of at least one pharmaceutically active ingredient capable of oral administration and which is releasable and orally ingestible by the patient after the inlaid triturate has disintegrated or has dissolved intraorally, which comprises the steps of:
• (i) providing the second portion as a single- or multi-layer compressed annular tablet, and
• (ii) molding the first portion as a triturate tablet into the annulus of (i).

A method of administering a pharmaceutical composition in unit dosage form as a compressed annular tablet molded triturate tablet for both intraoral and oral administration to a patient, which comprises:

• (a) as a first releasing portion, a molded triturate tablet comprising a therapeutically effective amount of at least one pharmaceutically active ingredient capable of intraoral administration;
• and
• (b) as a second releasing portion located around the said first portion, a therapeutically effective amount of at least one pharmaceutically active ingredient capable of oral administration and which is releasable and orally ingestible by the patient after the molded triturate has disintegrated or has dissolved intraorally, which comprises the steps of:
• (i) placing the pharmaceutical composition under the tongue or against the inner wall of the cheek or within the vestibular mucosa of said patient;
• (ii) retaining the pharmaceutical composition under the tongue or against the inner wall of the cheek or vestibular mucosa of the patient until the first releasing portion of the pharmaceutical composition containing the pharmaceutically active ingredient capable of intraoral administration has dissolved or has disintegrated thereby substantially releasing the pharmaceutically active ingredient capable of intraoral administration;
• and
• (iii) following step (ii) sucking or swallowing whole or chewing and swallowing the second releasing portion of the pharmaceutical composition.