Treatment of sinus headache

• US 5,478,565 A
• Filed: 03/27/1990
• Issued: 12/26/1995
• Est. Priority Date: 03/27/1990
• Status: Expired due to Fees

• Current Assignee: Warner-Lambert Company (Pfizer Inc.)
• Original Assignee: Warner-Lambert Company (Pfizer Inc.)
• Inventors: Geria, Navin M.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): BENSTON JR, WILLIAM E
• Application Number:
  US07/500,610
• Time in Patent Office: 2,100 Days
• Field of Search: 514/817, 514/257, 514/260, 514/456, 514/267, 514/179, 514/220, 514/853, 514/317, 514/777, 514/152, 514/154, 528/125, 528/407, 424/78, 424/458, 424/94.61, 424/81, 424/45, 424/434
• US Class Current: 424/434
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/135 having aromatic rings , e.g. ketamine, nortriptyline methadone A61K31/137
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/535 having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 27/16 Otologicals

Abstract

The present invention contemplates nasal compositions effective for relieving mammalian sinus headache associated with inflamed or congested turbinates, or both, accompanied by localized pain perceived on the septum, containing an anaesthetically effective amount of a non-addictive, rapidly absorbable anaesthetic component such anaesthetic being the sole active ingredient in the composition or being combined with a decongestant of the sympathomimetic amine class.

Claims

1. A topically applicable nasal composition capable of relieving mammalian sinus headache which comprises (i) an anaesthetically effective amount of an acid addition salt of dyclonine or pramoxine and (ii) an adrenergically effective amount of an acid addition salt of a sympathomimetic amine decongestant selected from the group consisting of an arylalkylamine, imidazoline and a cycloalkylamine incorporated in a pharmaceutically acceptable carrier.

2. A composition according to claim 1 wherein the sympathomimetic amine decongestant is selected from the group consisting of phenylephrine, epinephrine, ephedrine, desoxyphedrine, phenylpropanolamine, tuaminoheptane, naphazoline, oxymetazoline, tetrahydrozoline, xylometazoline, propylhexadrine and mixtures thereof.

3. A composition according to claim 1 wherein the arylalkylamine is oxymetazoline.

4. A composition according to claim 3 wherein the pharmaceutically acceptable carrier is in the form of a member selected from the group consisting of a nasal spray, nasal gel, nose drops and an insufflation.

5. A topically applicable nasal composition capable of eliciting a therapeutic response in the mucous membranes of the sinuses of a mammal which comprises (i) an acid addition salt of dyclonine or pramoxine in a concentration from about 0.01 per cent weight/weight to about 0.1 per cent weight/weight and (ii) an adrenergically effective amount of an acid addition salt of oxymetazoline, incorporated in a pharmaceutically acceptable carrier.

6. A topically applicable nasal composition capable of eliciting a therapeutic response in the mucous membranes of the sinuses of a mammal which comprises (i) an anaesthetically effective amount of an acid addition salt of dyclonine or pramoxine and (ii) an acid addition salt of oxymetazoline in a concentration from about 0.1 per cent weight/weight to about 1.0 per cent weight/weight, incorporated in a pharmaceutically acceptable carrier.

7. A topically applicable nasal composition capable of eliciting a therapeutic response in the mucous membranes of the sinuses of a mammal which comprises (i) an acid addition salt of dyclonine or pramoxine in a concentration from about 0.01 per cent weight/weight to about 0.1 per cent weight/weight and (ii) an acid addition salt of oxymetazoline in a concentration from about 0.1 per cent weight/weight to about 1.0 per cent weight/weight, incorporated in a pharmaceutically acceptable carrier.

8. A method for treating sinus headache in a mammal by administering a topically applicable nasal composition capable of eliciting a therapeutic response in the mucous membranes of the sinuses of said mammal which comprises an anaesthetically effective amount of an acid addition salt of dyclonine or pramoxine incorporated in a pharmaceutically acceptable carrier.

9. A method according to claim 8 wherein the pharmaceutically acceptable carrier is in the form of a member selected from the group consisting of a nasal spray, nasal gel, nose drops and an insufflation.

10. A method for treating sinus headache in a mammal by administering a topically applicable nasal composition capable of eliciting a therapeutic response in the mucous membranes of the sinuses of said mammal which comprises (i) an anaesthetically effective amount of an acid addition salt of dyclonine or pramoxine and (ii) an adrenergically effective amount of an acid addition salt of a sympathomimetic amine decongestant selected from the group consisting of an arylalkylamine, an imidazoline and a cycloalkylamine, incorporated in a pharmaceutically acceptable carrier.

11. A method according to claim 10 wherein the sympathomimetic amine decongestant is selected from the group consisting of phenylephrine, epinephrine, ephedrine, desoxyphedrine, phenylpropanolamine, tuaminoheptane, naphazoline, oxymetazoline, propylhexadrine and mixtures thereof.

12. A method according to claim 10 wherein the arylalkylamine is oxymetazoline.

13. A method according to claim 12 wherein the pharmaceutically acceptable carrier is a member selected from the group consisting of a nasal spray, nasal gel, nose drops and an insufflation.