Methods and compositions for the treatment of hearing disorders
AssigneeGateway Biotechnology, Inc.
InventorsJianxin BAO, Stephen H. WU, David STADERMANN
Life of this patent
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Abstract
Provided are methods and compositions for the treatment of neural disorders, such as hearing disorders. The methods can comprise a method for treating tinnitus or Meniere's disease or a symptom of tinnitus or Meniere's disease in a subject in need thereof by intranasally administering a therapeutically effective amount of NMDP or a salt thereof. Compositions can comprise an intranasal delivery formulation of a therapeutically effective amount of NMDP or a salt thereof for the treatment of neural disorders.
Claims120
A method for treating a hearing disorder or a symptom of a hearing disorder in a subject in need thereof comprising intranasally administering a therapeutically effective amount of NMDP or an L-type calcium channel blocker to the subject.
A method for treating a hearing disorder or a symptom of a hearing disorder in a subject in need thereof comprising:
- a. administering an L-type calcium channel blocker to the subject;
- b. assessing if the subject was responsive to the L-type calcium channel blocker;
- and
- c. administering a therapeutically effective amount of NMDP or a salt thereof to the subject if the subject was responsive to the L-type calcium channel blocker.
A method of selecting a subject in need thereof for treatment of tinnitus or Meniere's disease or a symptom of tinnitus or Meniere's disease comprising:
- a. administering an L-type calcium channel blocker to the subject;
- b. selecting the patient for treatment of tinnitus or Meniere's disease or a symptom of tinnitus or Meniere's disease if the subject was responsive to the L-type calcium channel blocker;
- and
- c. administering a therapeutically effective amount of NMDP or a salt thereof to the subject if the subject was responsive to the L-type calcium channel blocker.
A method of achieving a therapeutically effective area under the curve (AUC) extrapolated to infinity from dosing time (AUC0-infinity) of NMDP in a subject in need thereof, comprising intranasally administering an intranasal pharmaceutical composition to the subject, wherein the intranasal pharmaceutical composition comprises:
- (i) from about 0.2 to about 250 mg/kg NMDP or a pharmaceutically acceptable salt thereof;
- (ii) a buffer;
- and
- (iii) a surfactant,
- wherein the subject exhibits an AUC0-infinity of NMDP which is between 270 h*ng/ml and 340 h*ng/mL following administration of the intranasal pharmaceutical composition to the subject.
A pharmaceutical composition comprising a therapeutically effective amount of NMDP, wherein composition is formulated for intranasal administration, the composition comprising:
- a. a therapeutically effective amount of NMDP;
- b. a buffer;
- c. a penetration enhancer;
- and
- d. a surfactant.
A pharmaceutical composition comprising a therapeutically effective amount of NMDP, composition formulated for intranasal administration, the composition comprising:
- a. a therapeutically effective amount of NMDP;
- and
- b. a surfactant;
- c. a solvent;
- and
- d. a water-soluble cellulosic polymer.
A pharmaceutical composition comprising a therapeutically effective amount of NMDP, wherein the composition is formulated for intranasal administration, the composition comprising:
- a. a therapeutically effective amount of NMDP;
- b. a surfactant;
- c. a water-soluble cellulosic polymer;
- d. a solvent;
- and
- e. water.
A process for preparing an NMDP liquid composition, the process comprising the steps of:
- 1) dissolving Tween 80 (<2% w/w) separately in mPEG350 and PEG400;
- 2) mixing NMDP with the solutions from Step 1) to saturation solubility, or a desired effective concentration;
- 3) preparing an aqueous solution of HPMC or HPMC in buffer (<2% w/w) with a pH value in the range of about 6.4 to about 7.4;
- and
- 3) adding an aqueous HPMC solution or HPMC buffer from Step 3) to the respective solutions from Step 2) with agitation and allow the mixtures to stand to observe solution or suspension stability.
A pharmaceutical composition comprising a therapeutically effective amount of NMDP, wherein the composition is formulated for intranasal administration, the composition comprising:
- a. a therapeutically effective amount of NMDP;
- and
- b. a liquid vehicle, wherein the liquid vehicle further comprises
- i. a surfactant;
- ii. a water-soluble cellulosic polymer;
- iii. a solvent;
- and
- iv. water.
A pharmaceutical composition comprising a therapeutically effective amount of NMDP, wherein composition is formulated for intranasal administration, the composition comprising:
- a. a therapeutically effective amount of NMDP;
- b. a solvent;
- and
- c. water.
Dependencies are inferred from the claim text.