Claims for Patent: 12,257,218

Summary for Patent: 12,257,218

Title:	Pharmaceutical formulation
Abstract:	A formulation for oral administration comprises an expectorant, an analgesic, and at least one additional active ingredient having a modified release providing a therapeutic effect for each of the active ingredients for up to 12 hours.
Inventor(s):	Raghu Cavatur, Kevin Chen, Matthew Kaser, Hongchun Qiu, Ernest Joseph Woodhouse, Josef Borovicka, Elliot Wilkinson
Assignee:	RB Health US LLC
Application Number:	US17/667,746
Patent Claims:	1. A pharmaceutical composition comprising: (a) about 600 mg of guaifenesin; (b) about 30 mg of dextromethorphan or a pharmaceutically acceptable salt thereof; (c) about 110 mg of naproxen or a pharmaceutically acceptable salt thereof; (d) about 18 to 28 mg of hypromellose; and (e) about 8 to 14 mg of hydroxyethyl cellulose; wherein the pharmaceutical composition provides a therapeutic effect in respect of each of guaifenesin, naproxen, and dextromethorphan for 12 hours, wherein substantially all of naproxen dissolves within 30 minutes in a pH 6.8 phosphate buffer, and wherein the pharmaceutical composition is a bilayer tablet comprising an immediate release layer containing substantially all of the naproxen and at least about 100 mg of the guaifenesin and at least about 8 mg of the dextromethorphan, wherein the immediate release layer contains none of the hypromellose, and wherein the immediate release layer contains none of the hydroxyethyl cellulose. 2. The pharmaceutical composition of claim 1, further comprising 0.1-2% of sodium lauryl sulfate by weight of the total composition and 1-10% sodium bicarbonate by weight of the total composition. 3. The pharmaceutical composition of claim 2, wherein the sodium lauryl sulfate is in an amount of about 10-11 mg and the sodium bicarbonate is in an amount of about 30-60 mg. 4. The pharmaceutical composition of claim 3, wherein the immediate release layer contains substantially all of the sodium lauryl sulfate and substantially all of the sodium bicarbonate. 5. A pharmaceutical composition comprising: (a) about 600 mg of guaifenesin; (b) about 30 mg of dextromethorphan or a pharmaceutically acceptable salt thereof; (c) about 110 mg of naproxen or a pharmaceutically acceptable salt thereof; (d) about 10-11 mg of sodium lauryl sulfate; and (e) about 30-60 mg of sodium bicarbonate; wherein the pharmaceutical composition provides a therapeutic effect in respect of each of guaifenesin, naproxen, and dextromethorphan for 12 hours, wherein substantially all of naproxen dissolves within 30 minutes in a pH 6.8 phosphate buffer, and wherein the pharmaceutical composition is a bilayer tablet comprising an immediate release layer containing substantially all of the naproxen and at least about 100 mg of the guaifenesin and at least about 8 mg of the dextromethorphan, wherein the immediate release layer contains substantially all of the sodium lauryl sulfate and substantially all of the sodium bicarbonate. 6. The pharmaceutical composition of claim 5, further comprising 1-8% hypromellose by weight of the total composition and 1-2% hydroxyethyl cellulose by weight of the total composition. 7. The pharmaceutical composition of claim 6, wherein the hypromellose is in an amount of about 18 to 28 mg and the hydroxyethyl cellulose is in an amount of about 8 to 14 mg. 8. The pharmaceutical composition of claim 7, wherein the immediate release layer contains none of the hypromellose, and wherein the immediate release layer contains none of the hydroxyethyl cellulose.