IP Library Granted Patent US 8,415,331
Granted Patent B2
US 8,415,331 · App. 12/338,491 · Granted Apr 9, 2013

Doxycycline metal complex in a solid dosage form

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Quick Facts
Patent No.
US 8,415,331
App. No.
12/338,491
Granted
Apr 9, 2013
Kind
B2
Abstract

The present invention is a solid dosage form of a doxycycline metal complex. The present invention also includes a process for making a doxycycline metal complex in a solid dosage form. The process comprises the steps of (i) providing an aqueous solution of doxycycline or a physiologically acceptable salt thereof; (ii) admixing a metal salt with the aqueous solution; (iii) admixing a base to increase the pH of the aqueous solution, thereby forming a suspension of doxycycline metal; and (iv) drying the suspension, thereby forming a dry granulation of doxycycline metal complex.

Claims (15)

1. A solid dosage form comprising a doxycycline calcium complex for pharmaceutical administration, wherein the complex consists of doxycycline and calcium, and wherein the molar ratio of doxycycline to calcium in the complex is 1:1.

2. The solid dosage form of claim 1 , wherein said solid dosage form is selected from the group consisting of powders, granules, tablets, coated tablets, gelatin filled capsules, pellets, and chewable tablets.

3. The solid dosage form of claim 2 , wherein said solid dosage form is a chewable tablet.

4. A solid pharmaceutical dosage form comprising:

(i) a doxycycline calcium complex, wherein the complex consists of doxycycline and calcium in a solid form, and wherein the molar ratio of doxycycline to calcium in the complex is 1:1; and

(ii) one or more pharmaceutically acceptable excipients.

5. The composition of claim 4 , wherein said pharmaceutically acceptable excipient is selected from the group consisting of polymers, resins, plasticizers, fillers, lubricants, binders, disintegrants, granulating agents, solvents, co-solvents, surfactants, preservatives, sweetening agents, flavoring agents, buffering systems, antioxidants, pharmaceutical-grade dyes, pigments, and mixtures thereof.

6. The composition of claim 4 , wherein said pharmaceutically acceptable excipient is microcrystalline cellulose.

7. A solid dosage form comprising a doxycycline calcium complex, wherein the complex consists of doxycycline and calcium, wherein the molar ratio of doxycycline to calcium in the complex is 1:1, and wherein the complex was made by a process comprising the steps of:

(i) providing an aqueous solution of doxycycline or a physiologically acceptable salt thereof;

(ii) admixing a calcium salt with the aqueous solution;

(iii) admixing a base to increase the pH of the aqueous solution, thereby forming a suspension of doxycycline calcium complex; and

(iv) drying the suspension, thereby forming a dry granulation of doxycycline calcium complex.

8. A method of treating a bacterial infection in a subject, the method comprising:

administering to the subject a solid pharmaceutical dosage form comprising a solid doxycycline calcium complex, wherein the complex consists of doxycycline and calcium, and wherein the molar ratio of doxycycline to calcium in the complex is 1:1.

Assignments (6)
CORRECTIVE ASSIGNMENT TO CORRECT THE US PATENT NO. 8,050,873 PREVIOUSLY RECORDED ON REEL 040183 FRAME 0129. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Feb 22, 2018
From: WARNER CHILCOTT COMPANY, LLC
To: ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
Reel/Frame 045417/0593 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2016
From: WARNER CHILCOTT COMPANY, LLC
To: ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
Reel/Frame 040183/0129 →
SECURITY AGREEMENT Recorded Mar 30, 2011
From: WARNER CHILCOTT COMPANY LLC
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 026064/0607 →
RELEASE - REEL 023456, FRAME 0052 Recorded Mar 29, 2011
From: CREDIT SUISSSE AG, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
To: WARNER CHILCOTT COMPANY LLC
Reel/Frame 026042/0046 →
SECURITY AGREEMENT Recorded Nov 2, 2009
From: WARNER CHILCOTT COMPANY, LLC
To: CREDIT SUISSE, CAYMAN ISLANDS BRANCH, AS ADMINISTRATIVE AGENT
Reel/Frame 023456/0052 →
CHANGE OF NAME Recorded Jun 18, 2009
From: WARNER CHILCOTT COMPANY, INC.
To: WARNER CHILCOTT COMPANY, LLC
Reel/Frame 022835/0896 →