Single tank process for preparing tannate liquid and semi-solid dosage forms

1 . A manufacturing process for the conversion and incorporation of a salt or free base of an active pharmaceutical ingredient into a therapeutic liquid or semi-solid dosage form, the process comprising the steps of:

(a) dissolving the salt or free base of the active pharmaceutical ingredient in a pharmaceutically acceptable liquid in the presence of a dispersing agent and tannic acid under stirring, to form a dispersion wherein the tannic acid component is of either a natural or synthetic source;

(b) combining the tannate salt complex of the active pharmaceutical ingredient without isolation or purification with pharmaceutically acceptable excipients to generate a therapeutic dosage form.

2 . The process according to claim 1 wherein the dispersing agent provided in step (b) is selected from the group consisting of magnesium aluminum silicate, xanthan gum and cellulose compounds.

3 . The process according to claim 1 wherein the pharmaceutically acceptable liquid in step (a) is selected from the groups consisting of purified water, isopropyl alcohol, ethanol, glycerin, propylene glycol, mineral oil and mixtures thereof.

4 . The process according to claim 1 wherein without isolation or purification of the tannate salt or complex of the active pharmaceutical ingredient, the additional steps are:

(c) separately adding one or more of the following; thickening, suspending, coloring, sweetening and flavoring agents to water under stirring, to form a dispersion;

(d) adding the tannate salt suspension from step (a) to the dispersion in step (c), under stirring to form a mixture containing the tannate salt complex of the active pharmaceutical ingredient;

(e) separately adding one or more of the following; preservative, pH adjusting and anti-caking agents to a pharmaceutically acceptable liquid under stirring to form a dispersion; and

(f) adding the dispersion from step (e) to the mixture from step (d) under stirring, to generate a suspension dosage form, at a pH range of 3.5-8.0.

5 . A manufacturing process for the conversion and incorporation of a salt or free base of an active pharmaceutical ingredient selected from the group consisting of an antihistamine, a decongestant, an antitussive and an anticholinergic for incorporation into a therapeutic liquid or semi-solid dosage form, the process comprising the steps of:

(a) dissolving the salt or free base of the active pharmaceutical ingredient in a pharmaceutically acceptable liquid in the presence of a dispersing agent and tannic acid under stirring, to form a dispersion wherein the tannic acid component is of either a natural or synthetic source;

(b) combining the tannate salt complex of the active pharmaceutical ingredient without isolation or purification with pharmaceutically acceptable excipients to generate a therapeutic dosage form.

6 . The process according to claim 5 wherein the antihistamine active pharmaceutical ingredient is selected from the group consisting of: carbinoxamine, chlorpheniramine, pyrilamine, pheniramine, phenindamine, diphenhydramine, bromodiphenhydramine, brompheniramine, loratadine, desloratadine, fexofenadine, cetirizine, hydroxyzine, promethazine, acrivastine, triprolidine, meclizine, dimenhydrinate, triplennamine, doxylamine, diphenylpyrilamine, trimeprazine; and chlorcylizine.

7 . The process according to claim 5 wherein the antitussive active pharmaceutical ingredient is selected from the group consisting of: carbetapentane, dextromethorphan, diphenhydramine, codeine, hydrocodone, oxycodone, and morphine.

8 . The process according to claim 5 wherein the decongestant active pharmaceutical ingredient is selected from the group consisting of: phenylephrine, pseudoephedrine, ephedrine, diphenhydramine, cyproheptadine, phenyltoloxamine, and clemastine.

9 . The process according to claim 5 wherein the anticholinergic active pharmaceutical ingredient is methscopolamine.

10 . The process according to claim 5 wherein the antihistamine and decongestants active ingredients are provided as the bitartrate, maleate, citrate, chloride, bromide, acetate or sulfate salt.

11 . The process according to claim 5 wherein the tannic acid provided in step (a) is natural or synthetic.

12 . The process according to claim 5 wherein a mixture of antihistamine tannate and decongestant tannate salts are formed in step (b).

13 . The process according to claim 12 wherein the antihistamine tannate and decongestant tannate salts in step (b) comprise carbetapentane tannate, phenylephrine tannate and pyrilamine tannate.

14 . The process according to claim 12 wherein the antihistamine tannate and decongestant tannate salts in step (b) comprise pyrilamine tannate and phenylephrine tannate.

15 . The process according to claim 12 wherein the antihistamine tannate and decongestant tannate salts in step (b) comprise pseudoephedrine tannate and chlorpheniramine tannate.

16 . A manufacturing process for the conversion and incorporation of a salt or free base of an active pharmaceutical ingredient into a therapeutic liquid or semi-solid dosage form, the process comprising the steps of:

dissolving the salt or free base of the pharmaceutical ingredient and tannic acid in a pharmaceutically acceptable liquid to form a dispersion; and

adding at least one pharmaceutically acceptable excipient to said dispersion to generate a therapeutic dosage form.

17 . The process of claim 16 , further including completing the dissolving and adding steps in a single vessel.

18 . The process of claim 17 , further including generating said therapeutic dosage form without isolating or purifying a resulting tannate salt complex of the active pharmaceutical ingredient.

19 . The process of claim 16 , further including generating said therapeutic dosage form without isolating or purifying a resulting tannate salt complex of the active pharmaceutical ingredient.