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Use of Calcitonin for the Treatment of RA

a technology of rheumatoid arthritis and calcitonin, which is applied in the field of rheumatoid arthritis treatment with calcitonin, can solve the problems of premature death and substantial disability

Inactive Publication Date: 2012-08-30
AZRIA MOISE +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the disease is unchecked, it leads to substantial disability and premature death.

Method used

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  • Use of Calcitonin for the Treatment of RA
  • Use of Calcitonin for the Treatment of RA
  • Use of Calcitonin for the Treatment of RA

Examples

Experimental program
Comparison scheme
Effect test

example 1

Formulation 1 (3 Batches)

[0087]Preparation of Micronized 5-CNAC: Coarse 5-CNAC, which is to be micronized, is added to a jet mill (Air Jet Mill Gem T® Copley Scientific, Ltd., Nottingham, UK) using a 80 ceramic pan cake jet mill, 8 cm diameter, 6 bar N2, 0.5 mm nozzles with manual feed of about 700 g / h. The coarse 5-CNAC is jet milled and periodically sampled under microscope with reference ruler measurements to identify when the average desired micronized particle size is obtained. Three different batches are ground to create a mean particle size, i.e. D50=6 um, 35 um, and 46 um batches. Individual sieving of the separate micronized batches is then done by using a conical sieve mill (Quadro Comil, Quadro Engineering Incorporated 613 Colby Drive, Waterloo, Ontario, Canada N2V 1A1) with a U10, 813 um conical sieve, round beater, operating at 1500 rpm with throughput of about 150 kg / h.

[0088]Formulation 1-3. Salmon Calcitonin Formulation with 5-CNAC of Different Particle Size

Ingredient...

example 2

Preparation of Formulations 2-3

[0090]Alternatively, there are further formulations provided:

Formulation 2:

[0091]

Ingredient% for batchBatch mg per tabletRecombinant 0.120.6Salmon calcitonin5-CNAC (I)0.24a1.25-CNAC (II)45.36b226.8Avicel PH 101 (I)3a15aAvicel PH 101 (II)44.9b224.9bCrospovidone525Aerosil 200 PH0.31.5Magnesium stearate1.05Total tablet weight (mg)100500Unit weight (a + b) listed as 5-CNAC disodium salt, corresponding to combined weight of 200 mg 5-CNAC free acid.Unit weight (a + b) of Avicel PH 101 (I) and (II) corresponds to combined weight of Avicel PH 101.

Formulation 3

[0092]

Ingredient% for batchBatch mg per tabletRecombinant0.160.8Salmon calcitonin5-CNAC (I)2.1a4.8a5-CNAC (II)2.1b4.8b5-CNAC (III)41.4c218.4cAvicel PH 101 (I)3a15aAvicel PH 101 (II)44.9b224.7bCrospovidone525Aerosil 200 PH0.31.5Magnesium stearate1.05Total tablet weight (mg)100500Unit weight (a + b + c) listed as 5-CNAC disodium salt, corresponding to combined weight of 200 mg 5-CNAC free acid.Unit weight (...

example 3

Preparation of Formulation 4

[0104]The above mentioned formulation 2 is compressed into tablets with various hardness using Manesty Beta press or Fette 3090 using different compression forces. Resultant tablets having different dissolution profiles were tested in Rhesus Monkeys for oral absorption of sCT. Tablets and their physical properties are listed in Table 1 and 2 below:

TABLE 10.6 mgSpeed: 197600 tab / hrwhich is 27 rpmForceWeightWeightThicknessHardnessHardness(KN)(mg)RSD(mm)(Kp)rangeDTFriability5.5500.580.584.955.885.7-6.130 s6504.150.894.866.795.7-7.740 s0.737.1503.681.014.69.41 8.3-10.42 m 30 s-2 m 15 s0.258499.680.694.5210.24 9.8-10.93 m 40 s-5 m 35 s0.528.5502.040.934.4711.711.2-12.84 m 30 s-5 m 46 s0.259505.740.624.431211.7-12.66 m 15 s-7 m 55 s0.1410.2504.80.574.3113.7412.8-14.67 m 19 s-8 m 8 s

TABLE 20.8 mgSpeed: 329400 tab / hrwhich is 45 rpmForceWeightWeightThicknessHardnessHardness(KN)(mg)RSD(mm)(Kp)rangeDTFriability5.1497.010.674.882.942.4-3.120 s1.1 (severechipping)6.44...

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Abstract

The present invention relates to a novel use of calcitonin in rheumatoid arthritis, and to methods of treating and / or preventing rheumatoid arthritis and conditions associated therewith in mammals, particularly humans.In particular, a method is provided of preventing or / and treating rheumatoid arthritis in a patient in need thereof comprising administering to said patient a therapeutically effective amount of calcitonin, e.g. salmon calcitonin in free form or salt form, in a pharmaceutically acceptable oral delivery form, wherein the therapeutically effective amount of a calcitonin is delivered orally in a composition comprising the calcitonin and a delivery agent for calcitonin.

Description

FIELD OF THE INVENTION[0001]The present invention relates to a novel use of calcitonin in rheumatoid arthritis, and to methods of treating and / or preventing rheumatoid arthritis in mammals, particularly humans.BACKGROUND OF THE INVENTION[0002]Calcitonins, e.g. salmon, (Asu 1-7)-eel or human calcitonin, of the invention are compounds which are long-chain polypeptide hormones secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin is mainly known as a potent inhibitor of osteoclastic bone resorption, which implicates bone attachment of osteoclasts and enzymatic degradation. Furthermore, it was found that there are effects of Intranasal Salmon Calcitonin in Juvenile Idiopathic Arthritis in humans (Siamopoulou A. et al, 2001, Calcif Tissue Int 69: 25-30) and in the prevention of bone erosion and bone loss in rheumatoid arthritis in humans (Sileghem A., 1992, Annals of Rheumatic Diseases 51: 761-764). The degrada...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/23A61K9/00A61K9/14A61P19/02A61P29/00
CPCA61K38/23A61K31/609A61P9/02A61P19/02A61P19/08A61P25/04A61P29/00A61P43/00
Inventor AZRIA, MOISECHRISTIANSEN, CLAUS
Owner AZRIA MOISE
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