US2023346693A1PendingUtilityA1

Hot melt extrusion for pharmaceutical vaginal film products

61
Assignee: UNIV PITTSBURGH COMMONWEALTH SYS HIGHER EDUCATIONPriority: Jun 28, 2017Filed: May 3, 2023Published: Nov 2, 2023
Est. expiryJun 28, 2037(~10.9 yrs left)· nominal 20-yr term from priority
Inventors:Lisa Cencia RohanGalit Regev
A61K 9/0036A61K 9/7007A61K 31/4164A61K 31/505A61K 31/567A61K 35/747A61K 38/16A61K 47/10A61K 47/38A61P 31/04A61K 9/0034A61F 6/06A61K 45/06A61K 31/7052A61K 31/7088A61K 31/715A61K 38/164A61K 31/7016
61
PatentIndex Score
0
Cited by
0
References
0
Claims

Abstract

Hot melt extrusion is disclosed as a process for forming vaginal drug delivery films. The methods involve extruding a composition comprising one or more active pharmaceutical ingredients and one or more polymer carriers at an elevated temperature through a die to thereby provide the film. Films prepared by hot melt extrusion are also described.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method of preparing a vaginal drug delivery film, comprising: extruding through a die a composition comprising one or more active pharmaceutical ingredients, a high molecular weight polyethylene oxide carrier having a molecular weight of from 100,000 to 700,000 Da, a medium molecular weight polyethylene oxide carrier having a molecular weight of from 3000 to 8000 Da, and a polymethacrylate, to thereby provide the film. 
     
     
         2 . The method of  claim 1 , wherein the active pharmaceutical ingredient is a hydrophobic active. 
     
     
         3 . The method of  claim 1 , wherein the active pharmaceutical ingredient is a hydrophilic active. 
     
     
         4 . The method of  claim 1 , wherein the active pharmaceutical ingredient is a protein or peptide. 
     
     
         5 . The method of  claim 1 , wherein the active pharmaceutical ingredient is a bacteria. 
     
     
         6 . The method of  claim 1 , wherein the active pharmaceutical ingredient is an oligonucleotide or nucleotide. 
     
     
         7 . The method of  claim 1 , wherein the active pharmaceutical ingredient is a polysaccharide or sugar. 
     
     
         8 . The method of  claim 1 , wherein the active pharmaceutical ingredient is an antibiotic, antiviral, antifungal, steroid, cytotoxic, anti-proliferative, anti-inflammatory, analgesic, or diagnostic agent. 
     
     
         9 . The method of  claim 1 , wherein the composition comprises two or more active pharmaceutical ingredients. 
     
     
         10 . The method of  claim 9 , wherein the active pharmaceutical ingredients are an antibiotic and a probiotic. 
     
     
         11 . The method of  claim 9 , wherein the active pharmaceutical ingredients are a contraceptive and an anti-HIV agent. 
     
     
         12 . The method of  claim 9 , wherein the active pharmaceutical ingredients are two or more anti-HIV agents, anti-herpes agents, and/or anti-hepatitis C agents. 
     
     
         13 . The method of  claim 9 , wherein the active pharmaceutical ingredients are dapivirine and levonorgestrel. 
     
     
         14 . The method of  claim 9 , wherein the active pharmaceutical ingredients are metronidazole and  Lactobacillus . 
     
     
         15 . The method of  claim 1 , wherein the active pharmaceutical ingredient is dapivirine, metronidazole, griffithsin, levonorgestrel,  Lactobacillus , or any combination thereof. 
     
     
         16 . The method of  claim 1 , wherein the high molecular weight polyethylene oxide has a molecular weight of about 200,000 Da. 
     
     
         17 . The method of  claim 1 , wherein the medium molecular weight polyethylene oxide has a molecular weight of about 4000 Da. 
     
     
         18 . The method of  claim 1 , wherein the composition further comprises from about 1% to about 4% of a low molecular weight polyethylene oxide having a molecular weight of from 200 to 600 Da. 
     
     
         19 . The method of  claim 18 , wherein the low molecular weight polyethylene oxide has a molecular weight of about 400 Da. 
     
     
         20 . The method of  claim 1 , wherein the composition further comprises one or more polymers selected from the group consisting of polyvinyl pyrrolidone, hydroxyethyl cellulose, hydroxypropylmethyl cellulose, and combinations thereof. 
     
     
         21 . The method of  claim 1 , wherein the composition further comprises a plasticizer, an antioxidant, and disintegration agent. 
     
     
         22 . The method of  claim 1 , wherein the film is extruded through the die at a thickness of from 10 µm to 5 mm. 
     
     
         23 . The method of  claim 1 , wherein the film has a water content of less than 10% by weight. 
     
     
         24 . The method of  claim 1 , wherein the film is extruded at a temperature of from 40° C. to 250° C. 
     
     
         25 . The method of  claim 1 , further comprising extruding a second composition comprising one or more active pharmaceutical ingredients and one or more polymer carriers at an elevated temperature through a die on top of the film. 
     
     
         26 - 49 . (canceled)

Join the waitlist — get patent alerts

Track US2023346693A1 — get alerts on status changes and closely related new filings.

We store only your email — no account needed. See our privacy policy.