Medicament adsorbates and their preparation

• US 4,753,800 A
• Filed: 10/04/1985
• Issued: 06/28/1988
• Est. Priority Date: 10/04/1985
• Status: Expired due to Fees

• Current Assignee: Warner-Lambert Company Tabor Road Morris Plains New Jersey A Corporation of
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Mozda, Ronald F.
• Primary Examiner(s): Lusignan, Michael R.
• Application Number:
  US06/784,280
• Time in Patent Office: 998 Days
• Field of Search: 424/440, 424/441
• US Class Current: 424/440
• CPC Class Codes: A61K 9/143 with inorganic compounds
• CPC Class Codes: A61K 9/145 with organic compounds

Abstract

A medicament adsorbate and process for making same. The medicament adsorbate comprises a complex magnesium aluminum silicate having sorbed therein an edible wax and a medicament drug.

Claims

1. A medicament adsorbate which comprises an effective amount of a complex magnesium aluminum silicate, having sorbed therein a dispersion of an effective amount of a medicament drug in an effective amount of an edible wax.

2. The medicament adsorbate of claim 1 wherein the complex magnesium aluminum silicate is present in an amount of about 25 to about 91% by weight, the edible wax is present in an amount of about 8 to about 50% by weight, and the medicament drug is present in an amount of about 1 to about 50% by weight of the medicament adsorbate.

3. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group consisting of analgesics, antiasmatics, antitussives, antihistamines, antinauseants, decongestants, expectorants, alkaloids, laxatives, vitamins, anti-cholesterolemic and anti-lipid agents, appetite suppressants, anti-inflammatory agents and mixtures thereof.

4. The medicament adsorbate of claim 1 wherein the medicament drug is the expectorant guaifenesin.

5. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of antitussive materials consisting of dextromethorphan, dextromethorphan hydrobromide, noscapine, carbetapentane citrate, chlophedianol hydrochloride and mixtures thereof.

6. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of analgesics consisting of acetaminophen, ibuprofen, salicylamide and mixtures thereof.

7. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of antiasmatics consisting of metaproterenol, theophylline and mixtures thereof.

8. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of antihistamines, consisting of chlorpheniramine maleate, phenindamine tartrate, pyrilamine maleate, doxylamine succinate, phenyltoloxamine citrate, diphenhydramine hydrochloride, promethazine, triprolidine and mixtures thereof.

9. The medicament adsorbate of claim 1, wherein the medicament drug is selected from the group of decongestants, consisting of phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudophedrine hydrochloride, ephedrine and mixtures thereof.

10. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of alkaloids consisting of codeine phosphate, codeine sulfate, morphine and mixtures thereof.

11. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of laxatives consisting of phenolphthalein, danthron, bisocadyl and mixtures thereof.

12. The medicament adsorbate of claim 1 wherein the medicament drug is the anti-cholesterolemic and anti-lipid agent gemfibrozil.

13. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of anti-inflammatory agents consisting of ioxicam meclophenamic acid and mixtures thereof.

14. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of antinauseants consisting of dimenhydrinate, meclizine and mixtures thereof.

15. The medicament adsorbate of claim 1 wherein the medicament drug is selected from the group of appetite suppressants consisting of phenylpropanolamine hydrochloride, caffeine and mixtures thereof.

16. The medicament adsorbate of claim 1 wherein the medicament drug is the central nervous system stimulant nicotine.

17. The medicament adsorbate of claim 1 wherein the edible wax is selected from the group consisting of carnauba wax, candelilla wax, paraffin, castor wax, bees wax, stearic acid, stearyl alcohol, cetyl alcohol, esters of fatty alcohols and mixtures thereof.

21. The medicated composition of claim 9 wherein the pharmaceutically acceptable carrier is selected from a group consisting of a lozenge, a tablet, toffee, nougat, chewy candy and chewing gum.

18. A process for preparing a medicament adsorbate which comprises melting an effective amount of an edible wax to form a liquid, admixing an effective amount of a medicament drug selected from the group consisting of analgesics, antiasthmatics, antitussives, antihistamines, antinauseants, decongestants, expectorants, alkaloids, laxatives, vitamins, anti-cholesterolemic and anti-lipid agents, appetite suppressants, anti-inflammatory agents and mixtures thereof with the melted wax, admixing an effective amount of complex magnesium aluminum silicate with the melted wax-drug mixture to sorb the wax-drug mixture onto the complex magnesium aluminum silicate, cooling the particulate mass and recovering the medicament adsorbate product.

19. The process of claim 18 which comprises:

employing about 8 to about 50% by weight edible wax, about 1 to about 50% by weight medicament drug and about 25 to about 91% by weight complex magnesium aluminum silicate.

20. A medicated composition which comprises a pharmaceutically acceptable carrier and from about 1% to about 60% by weight of the final composition of a medicament adsorbate containing about 25 to about 91% by weight of the adsorbate of a complex magnesium aluminum silicate having sorbed therein, from about 1% to about 50% by weight of the adsorbate of a medicament drug selected from the group consisting of analgesics, antiasmatics, antitussives, antihistamines, decongestants, expectorants, alkaloids, laxatives, vitamins, anti-cholesterolemic and anti-lipid agents, appetite suppressants, anti-inflammatory agents and mixtures thereof and from about 8% to about 50% by weight of the adsorbate of an edible wax selected from a group consisting of carnauba wax, candelilla wax, paraffin, castor wax, beeswax, stearic acid, stearyl alcohol, cetyl alcohol, esters of fatty alcohols and mixtures thereof.

22. A medicated confectionary product comprising:

a bulking agent of up to about 99%;

a therapeutically effective amount of a medicament adsorbate comprising an effective amount of a complex magnesium aluminum silicate having sorbed therein a dispersion of an effective amount of a medicated drug in an effective amount of an edible wax,

said medicament adsorbate being admixed in the confectionary product,

all percents herein are by weight of the medicated confectionary product.

23. A medicated chewing gum product containing a therapeutically effective amount of medicament drug which comprises

a chewing gum composition in an amount up to about 99% comprising:

a gum base; and

a sweetener;

a therapeutically effective amount of a medicament adsorbate comprising an effective amount of a complex magnesium aluminum silicate having sorbed thereon a dispersion of an effective amount of a medicated drug in an effective amount of an edible wax,

said medicament adsorbate being admixed in the chewing gum composition,

all percents herein are by weight of the medicated chewing gum product.