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Methods and compositions for reducing parathyroid levels

A parathyroid, horizontal technology, applied in the direction of drug combinations, chemical instruments and methods, preparations for in vivo experiments, etc., can solve problems such as no recommendation for joint use

Inactive Publication Date: 2013-04-10
CYCTOCHROMA INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The guidance does not recommend the co-use of vitamin D supplementation and vitamin D hormone replacement therapy, consistent with the warning inserted by the Food and Drug Administration on the packaging of vitamin D hormone replacement products

Method used

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  • Methods and compositions for reducing parathyroid levels
  • Methods and compositions for reducing parathyroid levels
  • Methods and compositions for reducing parathyroid levels

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0131] Example 1 - Sustained release formulation

[0132] Nine oral vitamin D formulations were prepared by uniformly mixing the indicated amounts of the identified components and filling said mixture into hard gelatin capsules according to Table 2 below. Formulation 9 is an immediate release formulation according to the prior art, wherein MIGLYOL 812N is a trade name for caprylic / capric triglycerides, available from CONDEA Chemie GmbH, Cranford, NJ, USA. The formulation was formulated with 250 μg of 25-hydroxyvitamin D 3 A single dose equivalent to Yucatan minipigs (approximately 10kg) was administered. Each group contained 5 animals. 250 μg equivalent of 25-hydroxyvitamin D 3 A tenth group of Yucatan minipigs was administered intravenously.

[0133] Blood was collected pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, 168, 240, 336, 432, 504, 576, and 672 hours post-dose. Analysis of Serum 25-Hydroxyvitamin D by Liquid Chromatography Mass Spectrometry / Mass Spectrometry (LC ...

Embodiment 2

[0147] Example 2 - Pharmacokinetic Study of Minipigs Oral Capsules

[0148] The purpose of the study was to evaluate the administration of 3 consecutive days: a) 1 x 250 μg 25-hydroxyvitamin D 3Modified release (MR) capsules, b) 2 x 250 μg MR capsules, c) 4 x 250 μg MR capsules, d) 1 x 1000 μg MR capsules, e) 1 x 250 μg immediate release (IR) 25-hydroxyvitamin D 3 25-Hydroxyvitamin D in male Yucatan pigs (about 45 kg body weight) after capsules and f) 1 x 250 μg MR capsules 3 systemic absorption.

[0149] The MR formulation was prepared according to the formulation of Example 1, Group 7 above. In the case of 1000 μg MR capsules, 25-hydroxyvitamin D 3 The highest concentration of was offset by the relative decrease in ethanol.

[0150] To prepare the IR formulation, 25-hydroxyvitamin D3 (0.12% wt / wt; 250 μg per capsule) was dissolved in ethanol USP (2.32% wt / wt; solubilizer) and mixed with corn oil USP (97.54% wt / wt; main vehicle) and butylated hydroxytoluene (0.02% wt / wt;...

Embodiment 3

[0166] Example 3 - Study of Systemic Exposure in Minipigs Oral Capsules

[0167] The aim of this study was to assess systemic 25-hydroxyvitamin D in healthy normal male Yucatan pigs (up to 50-60 kg body weight) 3 The pigs were maintained on a diet containing adequate vitamin D intake and then dosed daily for 21 days as follows: a) 25 μg immediate release (IR) 25-hydroxyvitamin D 3 Capsules (group 1), b) 25 μg modified release (MR) 25-hydroxyvitamin D 3 Capsules (group 2), and c) 125 μg MR 25-hydroxyvitamin D 3 Capsules (group 3).

[0168] Based on Group 7 above, the formulation of Example 1 was prepared as an MR formulation. 25-Hydroxyvitamin D 3 Differences in concentrations were offset by relative changes in ethanol.

[0169] For the preparation of IR formulations, 25-hydroxyvitamin D 3 (0.12% wt / wt, 250 μg per capsule) dissolved in ethanol USP (2.32% wt / wt, solubilizer) and mixed with corn oil USP (97.54% wt / wt, primary vehicle) and butylated hydroxytoluene ( 0.02% w...

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Abstract

Methods and compositions for reducing serum parathyroid levels in, for example, chronic kidney disease patients are disclosed. In these methods, an effective amount of a modified release formulation of 25 -hydroxy vitamin D is orally administered to a patient suffering from secondary hyperparathyroidism to lower the patient' s serum intact parathyroid hormone (iPTH) level, while avoiding a surge in serum total 25 -hydroxy vitamin D.

Description

[0001] Cross References to Related Applications [0002] Pursuant to 35 U.S.C. §119(e), the benefit of U.S. Provisional Patent Applications 61 / 318,741, filed March 29, 2010, and 61 / 405,196, filed October 20, 2010, the disclosures of which are incorporated by reference at this. technical field [0003] The present disclosure relates broadly to methods and compositions for reducing serum parathyroid levels in patients with, for example, chronic kidney disease. More specifically, the present invention relates to methods and compositions comprising controlled release formulations of 25-hydroxyvitamin D for oral administration. Background technique [0004] Vitamin D 3 and vitamin D 2 (collectively referred to as "vitamin D") are fat-soluble ring-slit steroidal precursors of the provitamin D hormone. known as 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 Metabolites of vitamin D (collectively referred to herein as "25-hydroxyvitamin D") are fat-soluble steroid precursors ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/40
CPCA61K9/0002A61K9/4858A61K9/4866A61K31/592A61K31/593A61K2300/00A61P5/20A61K38/17A61K38/18A61K39/40A61K47/42A61K49/14C07K14/435C07K14/475C07K16/18C07K16/22
Inventor 萨米尔·P·塔巴什查理斯·W·比绍夫乔尔·Z·梅尔尼克埃里克·J·梅斯纳马丁·P·佩特科维奇杰伊·A·怀特
Owner CYCTOCHROMA INC
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