Medicament adsorbates with surfactant and their preparation

• US 4,716,033 A
• Filed: 03/27/1986
• Issued: 12/29/1987
• Est. Priority Date: 03/27/1986
• Status: Expired due to Term

• Current Assignee: Warner-Lambert Company (Pfizer Inc.)
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Denick, John Jr.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/845,209
• Time in Patent Office: 642 Days
• Field of Search: 514/770, 514/948, 514/949, 424/155, 424/48, 424/440, 424/441
• US Class Current: 424/48
• CPC Class Codes: A61K 9/143 with inorganic compounds

Abstract

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

Claims

1. A medicament adsorbate which comprises:

a complex magnesium aluminum silicate having sorbed therein a solution of medicament drug and a surfactant.

2. The medicament absorbate of claim 1 wherein the medicament drug is present in an amount of about 1 to about 35% by weight and the complex magnesium aluminum silicate is present in an amount of about 65% to about 99% by weight, all percents herein are by weight percent of the medicament absorbate.

3. The medicament absorbate of claim 1 wherein the surfactant is present in an amount of about 0.05% to about 4% by weight of the medicament absorbate.

4. the medicament absorbate of claim 1 further comprising a solvent content up to about 20% by weight of the medicament absorbate.

5. The medicament absorbate of claim 1 further comprising a solvent content from about 2% to about 15% by weight of the medicament absorbate.

6. The medicament absorbate of claim 1 wherein the surfactant is selected from the group consisting of sodium lauryl sulfate, Pluronics and mixtures thereof.

7. The medicament absorbate of claim 1 wherein the complex magnesium aluminum silicate has the following typical chemical analysis:

space="preserve" listing-type="tabular">______________________________________ Ratio to Percent by Weight Aluminum Oxide ______________________________________ Silicon dioxide 55 to 70 3.2 to 35 Magnesium oxide 2.9 to 25 0.17 to 12.5 Aluminum oxide 2.0 to 17 1 Ferric oxide 0.4 to 1.8 Calcium oxide 1.1 to 2.4 Sodium oxide 1.0 to 3.8 Potassium oxide 0.2 to 1.9 Ignition Loss 5.5 to 12.6 ______________________________________

8. The medicament adsorbate of claim 1 wherein the complex magnesium aluminum silicate has the following typical chemical analysis:

space="preserve" listing-type="tabular">______________________________________ Ratio to Percent by Weight Aluminum Oxide ______________________________________ Silicon dioxide 56 to 59 14.0 to 35 Magnesium oxide 21 to 24 5.2 to 12.0 Aluminum oxide 2.0 to 4.0 1 Ferric oxide 0.4 to 0.6 Calcium oxide 1.1 to 1.5 Sodium oxide 2.5 to 3.5 Potassium oxide 0.5 to 1.0 Ignition Loss 5.5 to 12.6 ______________________________________

9. A process for preparing a medicament adsorbate which comprises:

admixing a complex magnesium aluminum silicate with a medicament drug, a surfactant and a sufficient amount of solvent to dissolve the medicament drug and surfactant to form a mass containing said medicament drug and surfactant in an adsorbed condition, and recovering the medicament adsorabte.

10. The process of claim 9 wherein the solvent is present in amounts from about 10% to about 60% by weight of the medicament adsorbate.

11. The process of claim 9 wherein the medicament drug is present in an amount of about 1% to about 35% by weight and the complex magnesium aluminum silicate is present in an amount of about 65% to about 99% by weight, all percents herein are by weight percent of the medicament adsorbate.

12. The process of claim 9 wherein the surfactant is present in an amount of about 0.05% to about 4% by weight of the medicament adsorbate.

13. The process of claim 9 further comprising drying the mass to a final solvent content up to about 20% by weight of the medicament adsorbate.

14. The process of claim 9 wherein the solvent is present in an amount from about 1 to about 20 times by weight of the complex magnesium aluminum silicate.

15. 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 a complex magnesium aluminum silicate having sorbed therein a medicament drug and a surfactant.

16. The medicated composition of claim 15 wherein the pharmaceutically acceptable carrier is selected from a group consisting of a lozenge, a tablet, suspension, toffee, nougat, chewy candy and chewing gum.

17. A medicated confectionery product comprising:

a bulking agent of up to about 99%;

a therapeutically effective amount of a medicament adsorbate comprising;

a complex magnesium aluminum silicate having sorbed therein a medicament drug and a surfactant,

said medicament adsorbate being admixed in the confectionery product.

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

18. 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 a complex magnesium aluminum silicate having sorbed thereon a dispersion of a medicament drug and a surfactant,

said medicament adsorbate being admixed in the chewing gum composition,

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