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Biorelevant compositions

A related, compositional technology for biological testing, testing pharmaceutical formulations, emulsion delivery, etc.

Inactive Publication Date: 2015-04-29
BIORELEVANT COM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0036] The current state of the art does not give the separation of biologically relevant media for use in animals that typically preclinically evaluates pharmaceutical products from those used to evaluate different formulations of human drugs to select the best formulation for use in clinical testing , to assist in risk-reducing bioequivalence studies before or after marketing authorization, thereby programming the pharmaceutical development process of drug products

Method used

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  • Biorelevant compositions
  • Biorelevant compositions
  • Biorelevant compositions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0260] Typical biorelevant powder composition for the preparation of human FaSSIF (i.e. FaSSIF-V3 human) preparation

[0261] About 2 g of a solid biorelevant powder composition for manufacturing FaSSIF-V3 human was prepared by dissolving 1.622 g of sodium taurocholate in 10 ml of purified water at room temperature using a magnetic stirrer. After the sodium taurocholate was completely dissolved and a clear solution was obtained, 10 ml of t-butanol was added to the solution. Next, dissolve 0.009 g of diacyl phospholipids (especially PC) and 0.199 g of monoacyl phospholipids (especially diacyl phospholipids mixed with 50%-90% of monoacyl PC from partial enzyme digestion) into the solution Medium (alternatively the lipid material is added in steps). After the lipid component was completely dissolved, a clear to slightly yellow solution was obtained, and 0.128 g of sodium oleate was added to the solution. Transfer the clear to slightly yellow solution into suitable freeze-dr...

Embodiment 2

[0263] Preparation of human FaSSIF (i.e. FaSSIF-V3 human) by the solid bio-relevant composition shown in Example 1 kind)

[0264]

[0265] ＊ Partially digested diacylphospholipids contain approximately 80 wt% monoacyl PC

[0266] 1.741 g of the homogeneous powder composition from Example 1 was dissolved in maleic acid buffer containing buffer and osmotic agent (Example 14). Adjust the pH of the biorelevance medium to 6.7.

[0267] Alternatively, an equivalent weight of surfactant may be used in a liquid composition instead of a powder composition, such as an aqueous concentrated solution containing 10% to 60% by weight of surfactant and optional co-surfactant.

[0268] Alternatively, the ingredients may be added separately.

Embodiment 3

[0270] Preparation of human FaSSIF (i.e. FaSSIF-V3 human) by the solid bio-relevant composition shown in Example 1 kind)

[0271]

[0272]

[0273] ＊ Partially digested diacylphospholipids contain approximately 80 wt% monoacyl PC

[0274] 1.87 g of the homogeneous powder composition from Example 1 was dissolved in maleic acid buffer containing buffer and osmotic agent (Example 13). Adjust the pH of the biorelevance medium to 6.5.

[0275] Alternatively 3.5mmol of surfactant may be used in a concentrated aqueous solution containing 10% to 60% by weight of surfactant to replace the powder composition.

[0276] Alternatively, the ingredients may be added separately to prepare the fasted state medium.

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Abstract

Disclosed is a standardised aqueous biorelevant media for simulating fasted state stomach and fasted state upper small intestinal fluids of mammalian species, composed of surfactants occurring in the gastro intestinal tract of mammals comprising (a) at least 40 mole % to 95 mole % of one bile salt, and (b) the rest mole % being a combination of at least two surfactants, namely a diacyl phospholipid and a fatty acid including monovalent salts of the fatty acid, or a monoacyl phospholipid and a fatty acid including monovalent salts of the fatty acid, or a diacyl phospholipid and a monoacyl phospholipid and a fatty acid including monovalent salts of the fatty acid, or a diacyl phospholipid and a monoacyl phospholipid, which further is defined by a surface tension between 25 mN / m and 50 mN / m. Disclosed is further a homogeneous biorelevant composition for preparing fasted state biorelevant media characterised by a surface tension between 25 mN / m and 50 mN / m comprising the following surfactants: (a) at least 40 mole % to 95 mole % of one bile salt, and (b) the rest mole % being a combination of at least two surfactants, namely a diacyl phospholipid and a fatty acid including monovalent salts of the fatty acid, or a monoacyl phospholipid and a fatty acid including monovalent salts of the fatty acid, or a diacyl phospholipid and a monoacyl phospholipid and a fatty acid including monovalent salts of the fatty acid, or a diacyl phospholipid and a monoacyl phospholipid.

Description

technical field [0001] The present invention relates to biologically relevant compositions and methods of reconstituting biologically relevant media from the compositions. The present invention discloses, inter alia, novel compositions and preparations [0002] A method for preparing reproducible and consistent fasting state biorelevant media defined by selected biorelevant compositions and physicochemical parameters simulating fasting state fluids in the stomach and intestines. For oral administration, fasted state biorelevant media are suitable for solubility and solubility assessment of poorly water soluble compounds and their dosage forms. Background technique [0003] Upper gastrointestinal physiology and the importance of the site of dissolution [0004] Before the drug can be absorbed by the digestive tract, the drug must be in solution. In immediate-release dosage forms, the first site of release and dissolution is the stomach. The human stomach is a processing ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107G01N33/15
CPCG09B23/303G09B23/30G01N33/15G01N33/94
Inventor 马修·刘易斯·史蒂文·利史蒂夫·利珍妮弗·德雷曼巴斯琴·克洛弗马塞尔·阿恩特亚历山大·富克斯
Owner BIORELEVANT COM LTD