Selectable single dose auto-injector and methods of making and using same

Abstract

An auto-injector device for administering a liquid pharmaceutical composition, in which an end-user can select between doses that the device is capable of delivering. The end-user choices that translate into the selected doses can be based on end-user perceived severity of symptoms, end-user weight and other such factors. In some embodiments the auto-injector is configured to administer the one chosen dose only. In other embodiments, the auto-injector can deliver second and subsequent doses up to full dose of the pharmaceutical composition disposed in the injector. The auto-injector can provide visual, audio, and tactile feedback, alone or in combination, to the user to indicate the dose selected, instructions for use, and when the dose has been administered.

1 . A single use, selectable dose, self-contained, auto-injector comprising:
 a) an injector body;   b) a medicament reservoir within the injector body, the medicament reservoir comprising an active agent;   c) a selector coupled to the injector body, wherein the selector is configured to select one of predetermined and preset doses of the active agent;   d) an indicator placed on the injector body to indicate the dose selected;   e) a trigger present at distal end of the injector; and   f) a needle disposed within the injector body, wherein the needle extends beyond the injector body when said trigger is pressed against a user's skin to inject selected single dose of the active agent.   
     
     
         2 . The auto-injector of  claim 1 , wherein the predetermined and preset doses comprise a higher dose and a lower dose of the active agent. 
     
     
         3 . The auto-injector of  claim 2 , wherein the lower dose comprises one from about 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85% or 90% of the higher dose of the active agent. 
     
     
         4 . The auto-injector of  claim 1 , wherein the auto-injector is configured to prevent delivering more than one dose of medicament. 
     
     
         5 . The auto-injector of  claim 1 , wherein the selector comprises at least one of a dial, slider, rotating selector, thumb wheel or button. 
     
     
         6 . The auto-injector of  claim 1 , wherein the indicator comprises at least one of a visual indicator, audible indicator, or any combination thereof. 
     
     
         7 . The auto-injector of  claim 1 , wherein the active agent is selected from the group consisting of NSAIDs; COX-2 inhibitors; opioids; corticosteroids; triptans; immunomodulatory drugs; catecholamines; dopamine agonists; anticholinergic medications; anticonvulsants; antiepileptic drugs; dihydroergotamine; ibuprofen; aspirin; diclofenac; oxycodone; duloxetine; sumatriptan; rizatriptan; frovatriptan; zolmitriptan; naratriptan; morphine; epinephrine; teriflunomide; interferon beta-1a; interferon beta-1b; glatiramer acetate; fingolimod; mitoxantrone; dimethyl fumarate; natalizumab; Levodopa (L-dopa); carbidopa pramipexole; ropinirole; bromocriptine; selegiline; rasagiline; amantadine; entacapone; memantine; rivastigmine; galantamine; gabapentin; fludrocortisone; Hydrocortisone; hydrocortisone acetate; cortisone acetate; tixocortol pivalate; prednisolone; methylprednisolone; prednisone; triamcinolone acetonide; triamcinolone alcohol; mometasone; amcinonide; budesonide; desonide; fluocinonide; fluocinolone acetonide; halcinonide; betamethasone; betamethasone sodium phosphate; dexamethasone; dexamethasone sodium phosphate; fluocortolone; Hydrocortisone-17-butyrate; hydrocortisone-17-aceponate; hydrocortisone-17-buteprate; and prednicarbate. 
     
     
         8 . A method of administering to a patient an injectable composition comprising an active agent for acute indications, wherein said method comprises:
 i. providing a single use, selectable dose, self-contained auto-injector to a patient in need thereof, wherein said auto-injector comprises:
 a) an injector body; 
 b) a medicament reservoir within the injector body, the medicament reservoir comprising an active agent; 
 c) a selector coupled to the injector body, wherein the selector is configured to select one of predetermined and preset doses of the active agent; 
 d) an indicator placed on the injector body to indicate the dose selected; 
 e) a trigger present at distal end of the injector; and 
 f) a needle disposed within the injector body, wherein the needle extends beyond the injector body when said trigger is pressed against the patient's skin to inject selected single dose of the active agent, 
   ii. the patient selecting a single dose of the active agent using the selector; and   iii. the patient self-administering the single selected dose of the active agent.   
     
     
         9 . The method of  claim 8 , wherein the predetermined and preset doses comprise a higher dose and a lower dose of the active agent. 
     
     
         10 . The method of  claim 8 , wherein the auto-injector is configured to prevent delivering more than one dose of medicament. 
     
     
         11 . The method of  claim 8 , wherein the lower dose comprises one from about 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 85% or 90% of the higher dose of the active agent. 
     
     
         12 . The method of  claim 8 , wherein the higher dose is selected based on more severe symptom, and the lower dose is selected based on less severe symptom. 
     
     
         13 . The method of  claim 8 , wherein the active agent is selected from the group consisting of NSAIDs; COX-2 inhibitors; opioids; corticosteroids; triptans; immunomodulatory drugs; catecholamines; dopamine agonists; anticholinergic medications; anticonvulsants; antiepileptic drugs; dihydroergotamine; ibuprofen; aspirin; diclofenac; oxycodone; duloxetine; sumatriptan; rizatriptan; frovatriptan; zolmitriptan; naratriptan; morphine; epinephrine; teriflunomide; interferon beta-1a; interferon beta-1b; glatiramer acetate; fingolimod; mitoxantrone; dimethyl fumarate; natalizumab; Levodopa (L-dopa); carbidopa pramipexole; ropinirole; bromocriptine; selegiline; rasagiline; amantadine; entacapone; memantine; rivastigmine; galantamine; gabapentin; fludrocortisone; Hydrocortisone; hydrocortisone acetate; cortisone acetate; tixocortol pivalate; prednisolone; methylprednisolone; prednisone; triamcinolone acetonide; triamcinolone alcohol; mometasone; amcinonide; budesonide; desonide; fluocinonide; fluocinolone acetonide; halcinonide; betamethasone; betamethasone sodium phosphate; dexamethasone; dexamethasone sodium phosphate; fluocortolone; Hydrocortisone-17-butyrate; hydrocortisone-17-aceponate; hydrocortisone-17-buteprate; and prednicarbate.