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Liquid neurotoxin formulation stabilized with tryptophan or tyrosine

a neurotoxin and liquid technology, applied in the direction of drug compositions, peptide/protein ingredients, organic non-active ingredients, etc., can solve the problems of loss of physician time, undesirable presence of animal proteins such as hsa in pharmaceutical compositions, and inability to stabilize in liquid form most prior art formulations

Pending Publication Date: 2021-10-28
IPSEN BIOPHARM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text is about using certain amino acids to protect a protein from degradation in a liquid without any animal-derived proteins. This can help to improve the stability and quality of the protein composition.

Problems solved by technology

The presence of animal proteins such as HSA in pharmaceutical compositions is however undesirable because of the risk, even if low, of unwillingly transmitting animal borne infectious agents such as prions to a patient.
Most prior art formulations are however not stable in liquid form and are therefore stored in lyophilized or freeze-dried form.
This reconstitution step is associated with a loss of physician time, a risk of a dilution error and also a risk of contamination during the reconstitution process.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

examples

[0258]1. Preparation of Stable Liquid Botulinum Toxin A Formulations

[0259]Liquid botulinum toxin preparations containing 15 ng / mL of highly purified BoNT / A, 15% v / v polysorbate 20, an amino acid selected from tyrosine (Tyr), tryptophan (Trp) and cysteine (Cys) or a mixture of methionine (Met), tyrosine (Tyr), tryptophan (Trp) and cysteine (Cys) (Sigma Aldrich), and Phosphate Buffer Saline (PBS from Calbiochem) (140 mM NaCl, 10 mM sodium phosphate and 3 mM KCl at pH 7.4 at 25° C.) were prepared, filtered using 0.22 μm PVDF (polyvinylidenflourid) filters and stored in siliconized 2 mL glass syringes for 6 days at 40° C., after which a potency test was performed for each preparation.

[0260]For the potency test, the syringes containing the preparations were emptied in 2 mL glass vials (Chromacol, Gold) with lids containing PTFE treated rubber septa (Chromacol) or in 1.7 mL plastic micro centrifuge tubes (Axygen, Maximum Recovery) which both have low protein adsorption properties. The pre...

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PUM

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Abstract

The invention relates to stable liquid neurotoxin formulations which are free of animal proteins, comprising a surfactant, an amino acid selected from tryptophan and tyrosine, a buffer comprising sodium, chloride and phosphate ions, which have a pH between 5.5 and 8, and which are stable for 2 months. These compositions are suitable for use in therapy and in particular for administration to a patient to achieve a desired therapeutic or aesthetic effect. The invention also relates to the use of an amino acid selected from tryptophan and tyrosine to protect a proteinaceous neurotoxin from degradation in a liquid composition which is free of animal derived proteins.

Description

[0001]The present invention relates to animal protein free liquid neurotoxin formulations. In particular, the present invention relates to animal protein free liquid botulinum neurotoxin formulations stabilized with non proteinaceous excipients.[0002]The neurotoxin formulations described herein are suitable for use in therapy and in particular for administration to a patient to achieve a desired therapeutic or aesthetic effect.BACKGROUND OF THE INVENTION[0003]Clostridial neurotoxins naturally produced by clostridial strains are the most toxic biological agents known to date and at the same time are powerful tools for the treatment of a number of neuromuscular and endocrine disorders, including cervical dystonia, spasticity, blepharospasm, hyperhidrosis or sialorrhea. They also find uses in the aesthetic field for the smoothing of wrinkles.[0004]In order to be suitable for use as a pharmaceutical product, a neurotoxin composition must be such that it can be stored without significant...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/48A61K47/02A61K47/18A61K47/26A61K8/39A61K8/49A61K8/66A61Q19/08A61K9/00A61K8/19A61K8/00
CPCA61K38/4893A61K47/02A61K47/183A61K47/26A61K8/39A61K8/00A61K8/66A61Q19/08A61K9/0019A61K8/19A61K8/492A61K38/164A61K9/08A61P21/00A61P25/00A61P27/02A61P29/00A61P19/02A61P5/00A61P13/00A61P17/16A61P17/00A61Q19/00A61K8/64A61K8/44A61K8/20A61K8/24A61K2800/30A61K2800/52A61Q19/06Y02A50/30A61K47/22A61K31/198A61K31/405
Inventor JARSTAD, ANDERSFRIIS, ANNASTAHL, ULFGURELL, ANNAGREN, BARBROEDSTROM, EMILIAPICKETT, ANDREW
Owner IPSEN BIOPHARM LTD
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