Phosphodiesterase inhibitor treatment
View Patent ↗Methods and compositions are disclosed for the treatment of diseases or conditions produced by or associated with low cyclic nucleotide levels. The compositions comprise phosphodiesterase inhibitors and are formulated for intranasal and pulmonary administration.
1. A method for treating anosmia or hyposmia in a human in need thereof, the method comprising: administering to the human in need thereof, a steroid-free pharmaceutical dosage unit for intranasal administration comprising an effective amount of theophylline, wherein the steroid-free pharmaceutical dosage unit comprises less than 1 mg of theophylline and a pharmaceutically acceptable carrier.
2. The method of claim 1 , wherein the dosage unit comprises less than 500 μg, less than 250 μg, or less than 100 μg of the theophylline.
3. The method of claim 1 , wherein the dosage unit is formulated as a liquid or dry powder.
4. The method of claim 1 , wherein the dosage unit is administered at least once, twice, or thrice daily.
5. The method of claim 1 , wherein successful treatment comprises an increase in taste or smell acuity of at least 5%.
6. The method of claim 5 , wherein the increase in taste or smell acuity is accompanied by an increase in nasal mucus or saliva cAMP or cGMP levels.
7. A steroid-free pharmaceutical dosage unit for intranasal administration comprising an amount of theophylline effective for treating anosmia or hyposmia in a human in need thereof, wherein the steroid-free pharmaceutical dosage unit comprises less than 1 mg of the theophylline and a pharmaceutically acceptable carrier.
8. The dosage unit of claim 7 , that is a dry powder.
9. The dosage unit of claim 7 , that is a liquid.
10. The dosage unit of claim 7 , further comprising an excipient.
11. The dosage unit of claim 7 , wherein the pH of the dosage unit is from 5.5-7.5.
12. The dosage unit of claim 7 , that comprises less than 500 μg, less than 250 μg, or less than 100 μg of the theophylline.
13. The dosage unit of claim 7 , that comprises about 40 μg of the theophylline.
14. The dosage unit of claim 7 , that comprises about 20 μg of the theophylline.
15. The dosage unit of claim 10 , wherein the excipient is methylparaben and/or propylparaben.
16. The dosage unit of claim 9 , wherein the volume of the dosage unit is about 0.4 mL.
17. The dosage unit of any one of claim 7 , 8 , or 9 , having a theophylline unit dose from about 0.001 μg/kg to about 10.0 μg/kg of body weight per day.