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US 11,911,522 B2Granted
Process for the continuous manufacture of a polyisobutylene based transdermal patch
AssigneeMylan Inc.
InventorsRussell Adam Baird, Brad L. Barnett, Russell D. Beste
Life of this patent
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Abstract
The present invention is directed to a process for manufacturing a transdermal delivery device comprising a backing layer, a release liner, and an adhesive layer between the backing layer and release liner. More specifically, the invention is directed to a process of preparing an adhesive layer, wherein the adhesive layer is comprised of polyisobutylene and an active pharmaceutical ingredient.
Claims16
A continuous process for the production of an adhesive composition comprising:
- a) pre-processing a non-granulated high molecular weight polyisobutylene (HMW PIB) having a molecular weight ranging from about 200,000 g/mol to about 800,000 g/mol in a single-screw extruder to form a bulk BMW PIB material, wherein said bulk BMW PIB material is in a compressed, continuous feed form;
- b) extruding said bulk HMW PIB material in an extruding apparatus, wherein said HMW PIB is extruded;
- c) simultaneously extruding said extruded HMW PIB with low molecular weight polyisobutylene (LMW PIB) in said extruding apparatus to produce high shear so as to form an extruded melt, wherein a ratio of the amount of HMW PIB to LMW PIB in said melt ranges from about 50:50 to about 70:30;
- d) adding an active pharmaceutical ingredient (API) to said extruded melt to produce an extruded API/PIB melt;
- and
- e) discharging said extruded API/PIB melt to a die to form said adhesive composition, wherein said adhesive composition comprises about 93% to about 97% PIB and about 3% to about 7% API.
3 more elements
A continuous process for the production of an adhesive
- composition comprising:
- a) pre-processing a non-granulated high molecular weight polyisobutylene (HMW PIB) having a molecular weight ranging from about 425,000 g/mol to about 800,000 g/mol in a single-screw extruder to form a bulk HMW PIB material, wherein said bulk HMW PIB material is in a compressed, continuous feed form;
- b) extruding said bulk HMW PIB material having a molecular weight ranging from about 425,000 g/mol to about 800,000 g/mol in a twin-screw extruding apparatus, wherein said HMW PIB is extruded;
- c) simultaneously extruding said extruded HMW PIB with low molecular weight polyisobutylene (LMW PIB) in said extruding apparatus to produce high shear so as to form an extruded melt;
- wherein said LMW PIB has a molecular weight ranging from about 36,000 g/mol to about 75,000 g/mol;
- and wherein a ratio of the amount of HMW PIB to LMW PIB in said melt ranges from about 50:50 to about 70:30;
- d) adding an active pharmaceutical ingredient to said extruded melt to produce an extruded API/PIB melt;
- and
- e) discharging said extruded API/PIB melt to a die to form said adhesive composition, wherein said adhesive composition comprises about 93% to about 97% PIB and about 3% to about 7% API.
6 more elements
Dependencies are inferred from the claim text.