Solid drug delivery apparatus and formulations and methods of use

• US 9,320,877 B2
• Filed: 03/22/2010
• Issued: 04/26/2016
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Original Assignee: InCube Labs LLC. (In-Cube, Inc.)
• Inventors: Imran, Mir
• Primary Examiner(s): Gray, Phillip
• Application Number:
  US13/138,764
• Publication Number:
  US 20120296259A1
• Time in Patent Office: 2,227 Days
• Field of Search: 6048901-8921, 604/500, 604/503, 604/504, 604 65- 67, 604/20, 604/502
• US Class Current: 1/1
• CPC Class Codes: A61K 31/635 having a heterocyclic ring, e.g. sulfadiazine
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0009 involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis microelectromechanical systems A61K9/0097
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2813 Inorganic compounds
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

Embodiments provide apparatus and methods for delivering solid form medications such as pellets to various locations in the body. One embodiment provides an apparatus for in vivo delivery of medication pellets comprising a first chamber including an opening; a second chamber substantially surrounding the first chamber, a carriage disposed in the first chamber, a mechanism for transferring the medication pellets from the first chamber to the second chamber and a pusher plate. The carriage can hold and dispense a plurality of medication pellets. Each pellet contains a selected dose of drug to treat a medical condition. A catheter is positioned in the second chamber. The catheter has a lumen sized for the pellet, a proximal end inside the chamber and a distal end extending through chamber opening to deliver the pellet to a delivery site. The pusher plate engages and advances the pellet though the catheter to the delivery site.

Claims

1. A method for delivering a solid form medication comprising a drug, the method comprising:

storing a solid form medication within a container in the body of a patient for an extended period without substantial degradation or deleterious effect to the medication, wherein the medication comprises a drug for the treatment of a disease or condition; and

delivering the solid form medication from the container to a delivery site within the body so as to produce a therapeutic effect at a target tissue site for the treatment of the disease or condition wherein the delivering comprises transferring the solid form medication from the container to an outer chamber and through an opening in the outer chamber.

2. The method of claim 1, wherein the deleterious effect comprises a loss of potenty or therapeutic effectiveness of the drug.

3. The method of claim 1, wherein the medication is in pellet form.

4. The method of claim 1, further comprising:

dissolving the delivered solid form medication at the delivery site to yield a therapeutically effective amount of the drug at the target tissue site.

5. The method of claim 4, wherein the rate of disintegration of the solid form medication at the delivery site is enhanced through the use of a disintegration enhancing feature in or on the solid form medication.

6. The method of claim 4, further comprising:

determining a degradation state of the delivered solid form medication; and

delivering another dose of solid form medication responsive to the determined degradation state.

7. The method of claim 6, wherein the degradation state is determined using one of an optical, acoustical, or impedance sensor.

8. The method of claim 6, wherein the degradation state is determined by sending and receiving a signal from the delivered solid form medication.

9. The method of claim 8, wherein the signal is one of an optical, acoustic or electrical signal.

10. The method of claim 6, wherein the degradation state is combined with another parameter in determining whether to deliver another dose of medication.

11. The method of claim 10, wherein the other parameter is an in vivo concentration of the drug.

12. The method of claim 11, wherein the in vivo concentration is that at the delivery site, a target site, in blood or in cerebrospinal fluid.

13. The method of claim 10, wherein the other parameter is a dose frequency, a physiological parameter or a physiological parameter indicative of a medical condition or the onset of a medical condition.

14. The method of claim 1, wherein the medication comprises a pharmaceutical excipient.

15. The method of claim 14, wherein the excipient comprises a disintegrant configured to control a rate of disintegration of the solid medication at the delivery site.

16. The method of claim 14, wherein the excipient comprises a super disintegrant configured to accelerate a rate of disintegration of the solid medication at the delivery site.

17. The method of claim 1, further comprising:

delivering energy to the solid form medication to enhance a rate of disintegration of the solid form medication at the delivery site.

18. The method of claim 17, wherein the energy comprises thermal, electromagnetic, radiofrequency, acoustic or optical energy.

19. The method of claim 17, wherein the delivered energy produces structural defects in the solid form medication which enhance ingress of body tissue fluids into the solid form medication.

20. The method of claim 17, wherein the energy is delivered after the solid form medication is delivered to the delivery site.

21. The method of claim 1, wherein the target tissue site is at a different location from the delivery site.

22. The method of claim 21, wherein the target tissue site is non-appositional to the delivery site.

23. The method of claim 1, wherein the delivery tissue site is the brain, spinal cord, skeletal muscle, heart, lungs, liver, uterus, ovaries, testes, arteries, veins, prostate, blood, skin, thyroid gland, bone marrow, or kidney.

24. The method of claim 1, wherein the extended period is up to about one year.

25. The method of claim 1, wherein the extended period is up to about five years.

26. The method of claim 1, wherein the opening comprises the lumen of an elongate member, and delivering the solid form medication to the delivery site comprises delivering the solid form medication through the elongate member lumen to the delivery site.

27. The method of claim 1, wherein the elongate member has sufficient length to deliver the solid form medication to a different tissue location than the location of the container.

28. The method of claim 1, wherein the solid form medication is delivered from the container to the outer chamber using a drive source.

29. The method of claim 28, wherein the drive source comprises a linear inductance motor, a piezo-electric material, a solenoid, a shape memory wire, a fluidic drive source or a thermal drive source.

30. The method of claim 1, wherein the solid form medication is delivered at regular intervals.

31. The method of claim 30, wherein the interval is a daily, weekly or monthly interval.

32. The method of claim 1, wherein the solid form medication is delivered in response to a sensed biological parameter.

33. The method of claim 32, wherein the sensed biological parameter is predictive of a medical condition, a neurological seizure or an epileptic seizure.

34. The method of claim 1, wherein an interior of the container remains substantially isolated from the environment of the body during the extended period.

35. The method of claim 1, further comprising implanting the container at the delivery site in the body.

36. The method of claim 35, wherein at least a portion of the container is conformable, the method further comprising:

conforming the container to a shape of the delivery site.

37. The method of claim 35, wherein the container is implanted using minimally invasive methods.

38. The method of claim 1, wherein the drug comprises Furosemide.

39. The method of claim 1, wherein the drug comprises insulin.

40. The method of claim 1, wherein the drug comprises a vasodilating agent.

41. A method for delivering a solid form medication comprising a drug for the treatment of an epileptic seizure, the method comprising:

storing a solid form medication within a container implanted in the skull of a patient for an extended period without substantial degradation or deleterious effect to the medication, wherein the medication comprises a drug for the treatment of an epileptic seizure; and

delivering the solid form medication from the container to a delivery site within brain tissue so as to prevent an epileptic seizure or decrease the severity or duration of an epileptic seizure.

42. The method of claim 41, wherein the medication is in pellet form.

43. The method of claim 41, wherein the drug comprises Furosemide.

44. The method of claim 41, further comprising:

dissolving the delivered solid form medication within the cerebrospinal fluid (CSF) of the brain to achieve a selected concentration of the drug within the CSF to prevent the epileptic seizure or lessen the severity or duration of the epileptic seizure.

45. The method of claim 41, wherein the solid form medication is delivered in response to a sensed biological parameter predictive of an epileptic seizure.