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Pharmaceutical formulation and method of preparing the same

A preparation and medicine technology, applied in the direction of medicine formulation, drug combination, drug delivery, etc., can solve the problems of fast synthesis time, limited reagent feasibility, etc., achieve the effect of efficient preparation and avoid column purification steps

Inactive Publication Date: 2018-10-23
SEECURE TAIWAN CO LTD
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  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

However, the use of manual synthesis for clinical imaging is challenging for several reasons: 1) clinical reagents must meet stringent sterility and pyrogen requirements validated batch by batch; 2) batch-to-batch reproducibility is required to demonstrate Appropriate radiochemical yield, radiochemical purity, and other quality control assays; 3) synthesis times must be rapid when dealing with short half-lived radionuclide species; 4) clinical studies require multiple patient doses, which expose radiochemists to higher degree of radioactivity; and 5) the production cost and availability of this technology may limit the feasibility of this reagent in routine clinical practice

Method used

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  • Pharmaceutical formulation and method of preparing the same
  • Pharmaceutical formulation and method of preparing the same
  • Pharmaceutical formulation and method of preparing the same

Examples

Experimental program
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Effect test

example 1

[0061] Example 1: 68 Synthesis of Ga-DOTATATE

[0062] measured from 68 Ge / 68 Ga generator's 68 Ga-Elution File

[0063] In this example, HCl (ranging from 0.01N-1N) was used to elute from 68 Ge / 68 Ga generator obtained 68 GaCl 3 . For example, eluting with 0.3N and 0.6N HCl (10mL) from 68 Ge / 68 Ga generator's 68 GaCl 3 . Then on the next day, the elution volume (0.3N or 0.6N HCl, 6 mL) was divided into 12 tubes (0.5 mL / tube). The radioactivity of each tube was counted and the results are shown in Table 1 below.

[0064] Table 1: 68 Ga Elution Activity Profile

[0065]

Eluent 1 (0.6N HCl(aq))

Eluent 2 (0.3N HCl(aq))

1st aliquot

0.41uCi

0.79mCi

2nd fraction

0.35uCi

0.95mCi

3rd aliquot

0.903mCi

7.22mCi

4th aliquot

7.87mCi

3.10mCi

5th aliquot

7.55mCi

2.45mCi

6th aliquot

6.25mCi

1.51mCi

7th fraction

0.851mCi

0.73mCi

8th fraction

0....

example 2

[0083] Example 2: Positron Emission Tomography (PET) Imaging Study

[0084] to demonstrate the mix 68 Formulations of Ga-DOTATATE and the transchelator β-cyclodextrin (CD) were more effective than either alone 68 Ga-DOTATATE has the same or better imaging quality, and two animal models (colorectum and pancreas) with known neuroendocrine tumors were selected for imaging. Specifically, make 68 Ga-N4-tyrosine was incubated with plasma for up to 3 hours. Combine image data with 18 F-FDG (gold standard) and 68 Ga-DOTA (negative control) was used for comparison.

[0085] Briefly, imaging studies were performed using athymic nude mice (15±2 g) bearing human tumors (in the hind legs) derived from colorectal and pancreatic cell lines. Studies were performed when tumors were approximately 0.5 cm in diameter 21 to 28 days after inoculation. Nuclide scintigraphic images were obtained from micro-PET (Inveon) embedded in the gantries coordinate PET / CT data acquisition. each animal i...

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Abstract

A pharmaceutical formulation including a chelator-somatostatin receptor ligand and a transchelator is provided. The chelator-somatostatin receptor ligand is conjugated with a metal source or a radionuclide source, whereas the transchelator is capable of capturing free metal source or radionuclide source that is not conjugated to the chelator-somatostatin receptor ligand. By using such pharmaceutical formulation, the preparation of radiolabeled somatostatin analogues could be made more efficient, and is feasible for imaging of SSTR pathway-activated systems in cancers and neurological diseases.

Description

technical field [0001] The present invention relates generally to a pharmaceutical formulation, in particular to a pharmaceutical formulation comprising a chelator-somatostatin receptor ligand in admixture with a transchelator, a method for its preparation and use Methods of Imaging Pharmaceutical Formulations. Background technique [0002] The somatostatin receptor (SSTR) pathway is the main pathway for G protein degradation in mammalian cells, which is composed of immune enzymes that eventually lead to angiogenesis (VEGF, PDGFR) and cell proliferation associated with receptor tyrosine kinases. Sexual response cascade. Overexpression of SSTRs has been well documented in various neoplastic and neurological diseases. Most SSTR-carrying tumors can express multiple SSTR subtypes, with the SSTR2 subtype being the most prominent. The somatostatin analog "octreotide" binds with high affinity to the SSTR2 and SSTR5 subtypes, while having a low affinity to the SSTR3 subtype. Cur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K51/08A61K51/06
CPCA61K51/048A61K51/0482A61K51/06A61K51/083A61K51/088A61K9/0019A61P25/00A61P35/00A61K51/0474
Inventor 曹宁郭聪田杨敬文
Owner SEECURE TAIWAN CO LTD
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