Coated pharmaceutical compositions

• US 5,827,852 A
• Filed: 09/16/1994
• Issued: 10/27/1998
• Est. Priority Date: 04/30/1993
• Status: Expired due to Term

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Russell, Carmelita Macklin, Dines, Allen I., Upson, James Grigg
• Primary Examiner(s): HENLEY III, RAYMOND J
• Application Number:
  US08/307,537
• Time in Patent Office: 1,502 Days
• Field of Search: 424/456, 424/463, 424/475, 514/255, 514/256, 514/277, 514/290, 514/315, 514/325, 514/336, 514/568, 514/570, 514/613, 514/715
• US Class Current: 514/162
• CPC Class Codes: A61K 9/282 Organic compounds, e.g. fats
• CPC Class Codes: A61K 9/4891 Coated capsules; Multilayered drug free capsule shells with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004

Abstract

Pharmaceutical composition suitable for coating comprising a composition for oral administration in unit dosage form wherein said composition has been coated with from about 0.01% to about 10% by weight of the composition with a volatile aromatic compound selected from the group consisting of 3-1-menthoxy propane-1,2-diol, N-substituted-p-menthane-3-carboxamides and acyclic carboxamides and mixtures thereof.

Claims

1. An oral composition comprising:

a) a pharmaceutical active in a unit dosage form suitable for coating; and

b) a coating comprising a pharmaceutically-acceptable coating material and from about 0.01% to about 10% by weight of a volatile aromatic compound selected from the group consisting of 3-1-menthoxy propane-1,2-diol, N-substituted-p-menthane-3-carboxamides, acyclic carboxamides, and mixtures thereof.

2. The composition of claim 1 wherein said composition comprises a mixture of 3-1-menthoxy propane-1,2-diol and N-ethyl-p-menthane-3-carboxamide.

3. The composition of claim 2 wherein said composition comprises a mixture of 3-1-menthoxy propane-1,2-diol and N-ethyl-p-menthane-3-carboxamide in a weight ratio of about 3:

1, respectfully.

4. The composition of claim 1 wherein said composition comprises a mixture of 3-1-menthoxy propane-1,2-diol, N-ethyl-p-menthane-3-carboxamide and N, 2,3-trimethyl-2-isopropylbutanamide.

5. The composition of claim 4 wherein said composition comprises a mixture of 3-1-menthoxy propane-1,2-diol, N-ethyl-p-menthane-3-carboxamide and N, 2,3-trimethyl-2-isopropylbutanamide in a weight ratio of about 2:

1;

1, respectively.

6. The pharmaceutical composition of claim 1 wherein said pharmaceutical active is a colds active selected from the group consisting of analgesics, anti-inflammatories, anesthetics, antihistamines, decongestants, cough suppressants, demulcents, antitussives, expectorants, and mixtures thereof.

7. The pharmaceutical composition according to claim 6 wherein the pharmaceutical active is selected from the group consisting of pseudoephedrine, phenylpropanolamine, phenylephrine, ephedrine, dextromethorphan, chlophedianol, carbetapentane, caramiphen, noscapine, diphenhydramine, codeine, menthol, hydrocodone, hydromorphone, fominoben, glyceryl guaiacolate, terpin hydrate, ammonium chloride, N-acetylcysteine and bromhexine, ambroxol, chlorpheniramine, brompheniramine, dexchlorpheniramine, dexbromphreniramine, triprolidine, azatadine, doxylamine, tripelennamine, cyproheptadine, hydroxyzine, clemastine, carbinoxamine, phenindamine, bromodiphenhydramine, pyrilamine, acrivastine, AHR-11325, astemizole, azelastine, cetirizine, ebastine, ketotifen, lodoxamide, loratidine, levocabastine, mequitazine, oxatomide, setastine, tazifylline, temelastine, terfenadine, terbutaline, atropine, aminophylline, epinephrine, isoprenaline, metaproterenol, bitoterol, theophylline, albuterol, aspirin, acetaminophen, ibuprofen, naproxen, phenol, benzocaine, hexyl resorcinol, dyclonine, the pharmaceutically acceptable salts thereof, and mixtures thereof.

8. A pharmaceutical composition according to claim 1 wherein the composition is in a unit dosage form selected from the group consisting of tablets, capsules, pills, and lozenges.

9. A pharmaceutical composition according to claim 8 wherein the composition is in the form of a capsule selected from the group consisting hard gelatin capsules and soft gelatin capsules.

10. A pharmaceutical composition according to claim 9 wherein the composition is a soft gelatin capsule.

11. A method for treating cough, cold, cold-like, allergy, and flu symptoms in a human or lower animal, said method comprising administering to a human or lower animal in need of such treatment the composition of claim 1.

12. A method for treating cough, cold, cold-like, allergy, and flu symptoms in a human or lower animal, said method comprising administering to a human or lower animal in need of such treatment the composition of claim 2.

13. A method for treating cough, cold, cold-like, allergy, and flu symptoms in a human or lower animal, said method comprising administering to a human or lower animal in need of such treatment the composition of claim 5.