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Adjunctive therapy with 25-hydroxyvitamin D and articles therefor

A hydroxyvitamin and matrix technology, which is applied in the field of adjuvant therapy using 25-hydroxyvitamin D and its products, can solve problems such as the limitation of the efficacy of anti-absorption agents and the definition of supplementary programs.

Inactive Publication Date: 2018-06-08
OPKO IRELAND GLOBAL HLDG LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prevalence and persistence of SHPT even with vitamin D and calcium supplementation in patients receiving antiresorptive therapy suggests that an appropriate supplementation regimen has not been clearly defined for this patient population, and that the efficacy of antiresorptive agents is limited even by mild hypocalcemia and / or SHPT restrictions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0121] One embodiment of the modified release formulation for oral administration

[0122] Purified yellow beeswax and fractionated coconut oil were mixed in a 1:1 ratio and heated to 75°C with continuous mixing until a homogeneous mixture was obtained. Continue homogenizing the wax mixture while cooling to about 45 degrees Celsius. The active compound 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 Dissolve in absolute ethanol in a 1:1 ratio and add the ethanol solution to the molten wax mixture with continuous homogenization. The amount of ethanol added is in the range of 1 to 2 v / v%. Continue mixing until the mixture is homogeneous. The homogeneous mixture is filled into soft gelatin capsules. The capsules were rinsed immediately to remove any processing lubricants and dipped briefly in aqueous acetaldehyde to crosslink the gelatin shell. The concentration of the acetaldehyde solution and the soaking time were chosen to achieve the desired degree of crosslinking as de...

Embodiment 2

[0124] One embodiment of the formulation for intravenous administration

[0125] Heat TWEEN Polysorbate 20 to approximately 50 to 60°F and add 25-hydroxyvitamin D dissolved in a minimum volume of absolute ethanol with continuous stirring 3 . The resulting 25-hydroxyvitamin D 3 , absolute ethanol, and TWEEN polysorbate 20 were transferred to an appropriate volume of water for injection that had been thoroughly purged with nitrogen to remove all dissolved oxygen. Sodium chloride, sodium ascorbate, sodium phosphate (dibasic and monobasic) and disodium ethylenediaminetetraacetate were added, followed by vigorous stirring under a protective nitrogen atmosphere, to yield an aliquoted homogeneous mixture per 2 mL unit volume containing: 20mcg of 25-hydroxyvitamin D 3 ; less than 0.01% absolute alcohol; 0.40% (w / v) TWEEN polysorbate 20; 0.15% (w / v) sodium chloride; 1.00% (w / v) sodium ascorbate; 0.75% (w / v) Disodium hydrogen phosphate anhydrous; 0.18% (w / v) disodium hydrogen phosph...

Embodiment 3

[0127] Pharmacokinetic Testing in Dogs

[0128] Twenty male beagles were randomized into two comparison groups and received no vitamin D supplementation for the next 30 days. At the end of this time, each dog in Group #1 received 25-hydroxyvitamin D containing 25mcg in a controlled release formulation similar to that disclosed in Example 1 2 single soft capsule. Each dog in the other group (Group #2) received 25-hydroxyvitamin D containing 25mcg dissolved in medium chain triglyceride oil 2 of a single real-time release softgel. All dogs had not received food for at least 8 hours prior to dosing. Blood was drawn from each dog at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 15, 24, 36 and 72 hours post-dose. The collected blood was analyzed for the concentration of 25-hydroxyvitamin D contained, and the data were analyzed by treatment group. Mean blood 25-hydroxyvitamin D concentrations in dogs in Group #1 showed a slower and maximal increase compared to dogs in Group #2 (C max )smaller...

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PUM

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Abstract

Methods, compositions, and kits for adjunctive therapy using 25-hydroxyvitamin D are disclosed. The 25-hydroxyvitamin D may be administered with an agent that increases the risk of hypocalcemia, suchas cinacalcet or a pharmaceutically acceptable salt thereof, and / or an anticancer agent. The adjunctive therapy is effective to treat and prevent iatrogenic hypocalcemia and / or secondary hyperparathyroidism, as well as delay cancer progression and the time to a post-treatment skeletal related event.

Description

[0001] Cross References to Related Applications [0002] This article asserts the benefit of priority to U.S. Patent Application No. 14 / 866,155, filed September 25, 2015, pursuant to 35 U.S.C. §120. U.S. Patent Application No. 14 / 866,155 is a continuation-in-part of International Patent Application No. PCT / EP2015 / 068219 filed August 6, 2015, which claims August 7, 2014 under 35 U.S.C. § 119(e) The benefit of priority of filed U.S. Provisional Patent Application No. 62 / 034,604. The disclosure of each related application is incorporated herein by reference. Background technique [0003] 25-Hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 (collectively referred to as "25-hydroxyvitamin D"), vitamin D metabolites are provitamin D hormones that contribute to maintaining adequate levels of vitamin D hormones, calcium and phosphorus in the bloodstream. Primarily via one or more enzymes located in the liver, the prohormone 25-hydroxyvitamin D 2 by vitamin D 2 (ergocalciferol (ergoca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/137A61K31/592A61K31/593A61K47/44A61K9/48A61P13/12A61P3/02A61P35/00A61P5/20
CPCA61K31/592A61K31/593A61K45/06A61K2300/00A61K9/0019A61K9/4875A61K31/675A61K39/395A61K47/26A61K2039/505A61P3/02A61P3/14A61P5/06A61P5/20A61P5/22A61P7/08A61P13/12A61P19/08A61P19/10A61P35/00A61P35/04C07K2317/21C07K2317/76A61K9/0053A61K9/4825A61K31/135A61K31/137A61K31/663A61K47/06A61K47/14A61K47/38A61K47/44A61L2300/00A61P3/12
Inventor 乔尔·Z·梅尔尼克杰伊·A·怀特P·马丁·佩特科维奇萨米尔·P·塔巴什查理斯·W·比绍夫苏珊·H·皮尔斯斯蒂芬·A·斯特拉格内尔
Owner OPKO IRELAND GLOBAL HLDG LTD
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