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New emd formulation comprising pga

A preparation, surface stabilizer technology, applied in the field of new EMD preparations containing PGA

Active Publication Date: 2013-06-12
STRAUMANN HLDG AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nevertheless, the stability of EMD in the commercially available Straumann? Emdogain formulations with PGA is known to decrease rapidly over time

Method used

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  • New emd formulation comprising pga
  • New emd formulation comprising pga
  • New emd formulation comprising pga

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0134] Weight average molecular weight ( m W )

[0135] The weight average molecular weight was determined according to analytical method AM-S01 using GPC (Agilent) and the following parameters:

[0136] Eluent: Phosphate buffer pH 7.0

[0137] Precolumn: PSS Suprema 10 μm 100 ? 8 x 50 mm

[0138] PSS Suprema 10 μm 100 ? 8 x 300 mm

[0139] PSS Suprema 10 μm 1000 ? 8 x 300 mm

[0140] PSS Suprema 10 μm 100 ? 8 x 300 mm

[0141] Pump: Agilent 1100

[0142] Flow rate: 1.0 ml / min

[0143] Autosampler: Agilent 1100, injection volume 50 μl

[0144] Sample concentration: 2.0, 3.0 g / L

[0145] Temperature: 23°C

[0146] Detector: Agilent 1100 Rl

[0147] Calculation: PSS WinGPC Unity Version 7.20

[0148] Calibrate according to routine calibration with Pollulan molar mass standards

[0149] Unsterilized PGA and Kelcoloid since 2002 to 2009 ? The weight average molecular weight of O is disclosed in Table 1.

[0150] Table 1

[0151]

[0152] The table shows that ...

Embodiment 2

[0154] Sterilized PGA for Emdogain formulations was obtained from electron beam sterilization of non-sterile PGA as recommended by ISO 1137-2 (2006). The sterilization method includes the following steps:

[0155] 1. Sterility Assurance Level (SAL) 10 -6 (one milliomod) applied to 1 sterilized unit of PGA (100 g PGA / bag)

[0156] 2. Calculate the total bioburden of the sterilization unit (100 g PGA / bag): total bioburden = 100 g * CFU / g --> if the sterilization unit is changed, for example, the package is only 50 g PGA, then the total bioburden reduce

[0157] 3. Therefore, apply the total bioburden VDmax 25 --> min 25 kGy

[0158] During electron beam irradiation, PGA does not undergo crosslinking. The main process induced by electron beam irradiation is chain scission. Therefore, in this case, the weight average molecular weight (M W ) as a function of electron beam dose (R) can be simplified by Charlesby's equation (Eq. 1). The starting weight average molecular weigh...

Embodiment 3

[0166] PGA degradation.

[0167] They identified two types of degradation:

[0168] 1) Provides hydrolysis (pH change) of ester bonds of carboxylic acid and propylene glycol

[0169] 2) Degradation of glycosidic linkages in the polysaccharide backbone with reduced viscosity

[0170] They found that under acidic conditions, the ester groups in PGA were stable to hydrolysis and only the hydrolytic degradation of the polysaccharide backbone occurred. However, this statement was not confirmed under moderately acidic conditions (about pH 3-5). Hydrolytic cleavage of the polymer backbone occurs simultaneously with ester hydrolysis, and both pH and viscosity decrease.

[0171] The overall rate of hydrolysis of an ester can be written as the sum of the individual rates of the individual acid-catalyzed rates: k A [ester][ H + ], neutral rate: [Ester] and base-catalyzed hydrolysis rates: k B [ester][ Oh - ]

[0172]

[0173] in is the reaction rate constant, [ester], ...

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PUM

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Abstract

Enamel Matrix Derivative (EMD) proteins and enamel matrix proteins are widely used in clinical dentistry because of their ability to promote regeneration of soft and hard tissues and to reduce inflammation and infections. The present invention relates to the surprising finding that a pharmaceutical, dental and / or cosmetic formulation, which comprises purified Enamel Matrix Derivative (EMD) proteins and / or enamel matrix proteins and sterilized Propylene Glycol Alginate (PGA), wherein the sterilized PGA is obtained from non-sterilized PGA having a weight average molecular weight (Mwo) of between 250-500 kDa, is more stable over time, especially, the pH is more stable over time.

Description

[0001] technical field of invention [0002] The present invention relates to pharmaceutical, dental and / or cosmetic preparations comprising purified enamel matrix protein and / or enamel matrix derivative (EMD) protein. In particular, the present invention relates to stable formulations comprising enamel matrix protein and / or enamel matrix derivative (EMD) protein and sterilized propylene glycol alginate (PGA) having a weight average molecular weight of at least 130 kDa. Background technique [0003] Enamel matrix protein, which exists in the enamel matrix, is best known as the precursor of enamel. Before cementum is formed, enamel matrix proteins are deposited on the root surface of the developing root apex. There is evidence that deposited enamel matrix is ​​the trigger for cementum formation. Furthermore, the formation of cementum is intrinsically related to the development of periodontal ligament and alveolar bone. Enamel matrix protein can thus promote periodontal regen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/39A61K47/36A61Q11/00A61K6/898
CPCA61K6/54A61K8/498A61K8/64A61K9/08A61K38/39A61K47/36A61P1/02A61P19/00A61P29/00A61P31/00A61Q11/00C08L5/04
Inventor L.加拉姆切吉A.维塔尔
Owner STRAUMANN HLDG AG
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