Doxycycline metal complex in a solid dosage form
View Patent ↗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.
1. A process for making a solid dosage form comprising a doxycycline calcium complex, wherein the complex consists of doxycycline and calcium, the process comprising the steps of:
(i) providing an aqueous solution of doxycycline or a physiologically acceptable salt thereof;
(ii) admixing a calcium salt with said aqueous solution;
(iii) admixing a base to increase the pH of said aqueous solution, thereby forming a suspension of doxycycline calcium complex; and
(iv) drying said suspension, thereby forming a dry granulation of doxycycline calcium complex.
2. The process of claim 1 , wherein said aqueous solution of doxycycline or a physiologically acceptable salt thereof is made by dissolving doxycycline or a physiologically acceptable salt thereof in an aqueous solution resulting in a solution with a pH range of about 1 to about 8.
3. The process of claim 1 , wherein said calcium salt is calcium chloride.
4. The process of claim 1 , wherein said base is sodium hydroxide.
5. The process of claim 1 , wherein said granulation has a moisture level of less than about 10 wt. %.
6. The process of claim 1 , wherein said drying step is performed by a process selected from the group consisting of: spray drying, fluid-bed drying, tray drying, decanting, evaporating, freeze drying, and combinations thereof.
7. The process of claim 1 , further comprising the step of admixing one or more pharmaceutically acceptable-excipients, prior to said drying step.
8. The process of claim 1 , further comprising the step of admixing one or more pharmaceutically acceptable-excipients, after forming said granulation.
9. The process of claim 1 , further comprising the step of compressing said granulation, thereby forming tablets.
10. The process of claim 1 , wherein said doxycycline or a physiologically acceptable salt thereof is selected from the group consisting of: doxycycline hyclate, doxycycline monohydrate, doxycycline carrageenate, doxycycline phosphate, and mixtures thereof.
11. A process for making a solid dosage form comprising a doxycycline calcium complex, wherein the complex consists of doxycycline and calcium, the process comprising the steps of:
(i) providing an aqueous solution of doxycycline or a physiologically acceptable salt thereof;
(ii) admixing a calcium salt with said aqueous solution;
(iii) admixing a base to increase the pH of said solution, thereby forming a suspension of doxycycline calcium complex;
(iv) admixing one or more pharmaceutically acceptable-excipients with said suspension, thereby forming a wet granulation; and
(v) drying said wet granulation.