Misoprostol Composition

• US 20170112854A1
• Filed: 12/22/2016
• Published: 04/27/2017
• Est. Priority Date: 07/26/2012
• Status: Abandoned Application

• Current Assignee: Ferring BV (Ferring Holding SA)
• Original Assignee: Ferring BV (Ferring Holding SA)
• Inventors: Powers, Barbara L., Robertson, Steven
• Application Number:
  US15/388,157
• Publication Number:
  US 20170112854A1
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/5575 having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
• CPC Class Codes: A61K 38/095 Oxytocins; Vasopressins; Related peptides
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/0036 Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
• CPC Class Codes: A61P 15/04 for inducing labour or abortion; Uterotonics
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to the use of misoprostol for the induction of labour in a pregnant female, and in particular to the use of a sustained delivery device or insert containing substantially 200 μg misoprostol for intravaginal use. The use encompasses methods of therapy as well as compositions for use in such methods.

Claims

1-8. -8. (canceled)

9. A method of achieving one or more of:

(i) a reduction in the incidence of category II foetal heart rate pattern;

(ii) a reduction in incidences of intrapartum resuscitation;

(iii) reduced use of tocolytics;

(iv) a reduced incidence of meconium in amniotic fluid;

(v) a reduced requirement for a caesarean delivery during first hospitalisation;

(vi) a reduced requirement for instrumented vaginal delivery during first hospitalisation; and

(vii) a reduced incidence of postpartum haemorrhage.

in a female induced for labour due to pre-eclampsia, said method comprising administering intravaginally to the female an insert comprising a cross-linked polyurethane reaction product of a polyethylene glycol, a triol and a diisocyanate, the insert containing 200 μ

g misoprostol;

(i), (ii), (iii), (iv), (v), (vi), and (vii) being reduced in comparison to the administration of said insert containing 10 mg dinoprostone.

39. The method of claim 9, wherein the insert is a sustained or controlled delivery device.

40. The method of claim 9, wherein the insert comprises retrieval means for withdrawal of the insert.

41. The method of claim 9, wherein the method reduces at least the incidence of category II foetal heart rate pattern.

42. The method of claim 9, wherein the method reduces at least incidences of intrapartum resuscitation.

43. The method of claim 9, wherein the method reduces at least use of tocolytics.

44. The method of claim 9, wherein the method reduces at least incidence of meconium in amniotic fluid.

45. The method of claim 9, wherein the method reduces at least requirement for a caesarean delivery during first hospitalisation.

46. The method of claim 9, wherein the method reduces at least requirement for instrumented vaginal delivery during first hospitalisation.

47. The method of claim 9, wherein the method reduces at least incidence of postpartum haemorrhage.

10-38. -38. (canceled)

48. A method of achieving:

(i) a reduction in the incidence of category II foetal heart rate pattern;

(ii) a reduction in incidences of intrapartum resuscitation;

(iii) reduced use of tocolytics;

(iv) a reduced incidence of meconium in amniotic fluid;

(v) a reduced requirement for a caesarean delivery during first hospitalisation;

(vi) a reduced requirement for instrumented vaginal delivery during first hospitalisation; and

(vii) a reduced incidence of postpartum haemorrhage.

in a female induced for labour due to pre-eclampsia, said method comprising administering intravaginally to the female an insert comprising a cross-linked polyurethane reaction product of a polyethylene glycol, a triol and a diisocyanate, the insert containing 200 μ

g misoprostol;

(i), (ii), (iii), (iv), (v), (vi), and (vii) being reduced in comparison to the administration of said insert containing 10 mg dinoprostone.