Method of Treating a Child with Central Precocious Puberty using an Extended Release Composition

a technology of precocious puberty and composition, which is applied in the direction of endocrine system disorder, pharmaceutical non-active ingredients, infusion syringes, etc., can solve the problems of inconvenient effective period, inconvenient preparation and administration, and insufficient/inconvenient treatment period, so as to reduce the mean bone age of pediatric patients, reduce the mean bone growth velocity, and reduce the mean bone age of children

Inactive Publication Date: 2020-10-22
TOLMAR INT LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0020]In some embodiments, the extended release composition may reduce the mean bone growth velocity in a child or pediatric patient with CPP by about 25% over about a twelve-month treatment period. In some embodiments, administration of the extended release composition may reduce the child's mean ratio of bone age to chronological age at the t

Problems solved by technology

Despite the availability of GnRH-based treatments for CPP, limitations in current treatment options emphasize the continuous need for novel compositions with desirable extended release properties for the prolonged release of GnRH or GnRH agonists for treating CPP in children of at least 2 years of age.
However, all currently approved and marketed treatments for CPP in children have limitations and disadvantages, such as difficulty of formulation preparation and administration, inconsistent dosing issues, inadequate/inconvenient effective period (i.e., the interval

Method used

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  • Method of Treating a Child with Central Precocious Puberty using an Extended Release Composition
  • Method of Treating a Child with Central Precocious Puberty using an Extended Release Composition
  • Method of Treating a Child with Central Precocious Puberty using an Extended Release Composition

Examples

Experimental program
Comparison scheme
Effect test

example 1

rocedure for Preparation of Biodegradable Polymer

[0133]In a jacketed stainless steel polymerization vessel, appropriate amounts of lactide and glycolide are added and the vessel contents are placed under a nitrogen atmosphere. The temperature of the vessel is increased until the reagents melt. An appropriate amount of an alkanediol is then added, followed by addition of stannous octanoate catalyst. The vessel is then heated at about 135-145° C. under nitrogen atmosphere for about 3-4 hours with constant stirring. Then, to remove unreacted lactide and glycolide monomers, the vessel is evacuated and the monomers are vacuum distilled out of the polymerization mixture. The hot melt is then extruded into cooling pans. After cooling, the solid mass is cryo-ground to a fine powder and dried.

example 2

on and Administration of a Leuprolide Acetate Extended Release Composition

[0134]An extended release composition for use as a subcutaneous in situ depot in a pediatric patient 2 years of age or older for use as an effective treatment for CPP was prepared using a biodegradable polymer as prepared in Example 1. Components of the extended release composition of the invention are detailed in Table 1 below:

TABLE 1Extended Release Composition Reconstituted Drug ProductReconstitutedLeuprolide acetate delivered 45 mgDrug ProductApproximate leuprolide free base 42 mgequivalentPLG polymer delivered165 mgNMP delivered165 mgApproximate administered375 mgformulation weightApproximate injection volume0.375 mL

[0135]The extended release composition is comprised of 165 mg of 85:15 poly(D,L-lactide-co-glycolide) (PLG) copolymer segments dissolved in 165 mg of NMP organic solvent. The biodegradable polymer is polymerized using a 1,6-hexanediol core unit, and is therefore hydroxyl terminated at its dist...

example 3

h Clinical Study for Treating Children with CPP

[0137]A multi-center, open-label, single arm, adaptive design was conducted to evaluate the efficacy and safety of the extended release composition described in Example 2 in treating pediatric patients 2 years of age or older with CPP. 114 male and female children suspected of having CPP, but who had not yet ever been treated with GnRH agonist based therapies, were administered a subcutaneous injection of a stimulation composition consisting of leuprolide acetate solution at a dose of either 20 μg / kg or 500 μg total depending on physician discretion, in order to confirm an initial diagnosis of CPP. Of the 114 subjects enrolled and screened, 50 children did not receive any dose of the extended release composition as they failed to meet additional screening criteria beyond confirmed CPP diagnosis and where therefore excluded from the instant clinical trial. The mean age was 7.5 years (range 4-9 years) at the start of treatment. Additional...

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Abstract

An extended release formulation is provided for use in a method for the treatment of Central Precocious Puberty (CPP) in pediatric patients 2 years of age or older. The extended release formulation comprises leuprolide or a pharmaceutically acceptable salt thereof, a biodegradable polymer, and a biocompatible organic solvent. The biodegradable polymer is comprised of poly(lactide-co-glycolide) (PLG) copolymer segments, poly(lactic acid-co-glycolic acid) (PLGA) copolymer segments, poly(lactide) (PL) polymer segments, poly(lactic acid) (PLA) polymer segments, or a combination thereof. The extended release formulation is administered as a subcutaneous injection of a flowable composition that forms a solid in situ depot. The extended release formulation releases leuprolide for a period of about 6 months for the effective treatment of CPP within a pediatric patient.

Description

FIELD OF THE INVENTION[0001]This application pertains to the field of treating central precocious puberty (CPP) in children of at least 2 years of age using biodegradable polymer compositions that may be administered into the body with syringes or needles for the delivery of a GnRH agonist into the body over an extended period of time.BACKGROUND OF THE INVENTION[0002]Precocious Puberty (PP) is characterized by early onset of pubertal changes to a child of at least 2 years of age. PP is further divided into two classifications: Peripheral Precocious Puberty (PPP) or Central Precocious Puberty (CPP) (Fuqua J S. “Treatment and outcomes of precocious puberty: an update”. J Clin Endocrinol. Metab. 2013; 98(6): 2198-2207). PPP is defined by early sexual development prompted by sex steroids resulting from abnormal endogenous or exogenous sources such as disease or environmental exposure. PPP associated symptoms, such as ambiguous genital development or virilization in females, can result f...

Claims

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Application Information

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IPC IPC(8): A61K38/09A61K47/34A61K47/22A61P15/00A61K9/00A61M5/19
CPCA61K38/09A61K47/34A61M5/19A61K9/0019A61K47/22A61P15/00A61K9/0024A61P5/02
Inventor NANGIA, AVINASHMCLANE, JOHN ARTHUR
Owner TOLMAR INT LTD
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