Treatment of moderate to very severe glabellar lines and lateral canthal lines
AssigneesIpsen Biopharm Ltd., Galderma Holding SA
InventorsAndrew Pickett, Birgitta Almegård, Charlotta Gauffin, Aleksandra Karin, Anna Nilsson, Axel Emilson
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Abstract
Disclosed herein are methods of treatment of moderate to severe and very severe glabellar lines and lateral canthal lines using liquid botulinum neurotoxin compositions. Also disclosed are liquid compositions of botulinum neurotoxin.
Claims25
A method of treating moderate to severe lateral canthal lines (LCL) in a human subject having LCL, comprising administering to the subject 30 to 75 LD50 units of a RelabotulinumtoxinA by subdermal, transdermal, intradermal, or intramuscular injection of a liquid composition comprising 10 to 200 LD50 units per mL of the RelabotulinumtoxinA, thereby reducing the appearance of moderate to severe LCL, wherein the liquid composition has a pH between 6.0 and 7.5 and further comprises:
- (a) sodium chloride (NaCl) at a concentration of 100-300 mM;
- (b) potassium chloride (KCl) at a concentration of 1-25 mM;
- (c) two to four sources of phosphate ions independently selected from sodium phosphate, potassium phosphate, di-sodium hydrogen phosphate dehydrate, and sodium dihydrogen phosphate dehydrate, wherein each source of phosphate ions is independently at a concentration of 1-50 mM;
- (d) at least one amino acid selected from alanine, valine, leucine, isoleucine, methionine, phenylalanine, tyrosine, and tryptophan at a concentration of about 0.75 to about 2.25 mg/mL;
- and
- (e) at least one non-ionic surfactant selected from a polysorbate and a nonoxynol at a concentration of about 0.1% (v/v) to about 1.5% (v/v);
- wherein the liquid composition is not reconstitution from a lyophilized or freeze-dried form by a physician prior to administration;
- and
- wherein the LD50 unit value is determined using a gelatine phosphate buffer.
A method of treating moderate to severe lateral canthal lines (LCL) in a human subject having LCL, comprising administering to the human subject 30 to 75 LD50 units of a RelabotulinumtoxinA by subdermal, transdermal, intradermal, or intramuscular injection of a liquid composition having a pH between 6.0 and 7.5 comprising the RelabotulinumtoxinA and:
- (i) 100 to 300 mM of a first buffering agent selected from sodium chloride, potassium chloride, sodium phosphate, potassium phosphate, di-sodium hydrogen phosphate dehydrate, or sodium dihydrogen phosphate dehydrate;
- (ii) 1 to 25 mM of a second buffering agent selected from sodium chloride, potassium chloride, sodium phosphate, potassium phosphate, di-sodium hydrogen phosphate dehydrate, or sodium dihydrogen phosphate dehydrate;
- (iii) 1 to 25 mM of a third buffering agent selected from sodium chloride, potassium chloride, sodium phosphate, potassium phosphate, di-sodium hydrogen phosphate dehydrate, or sodium dihydrogen phosphate dehydrate;
- (iv) 1 to 25 mM of a fourth buffering agent selected from sodium chloride, potassium chloride, sodium phosphate, potassium phosphate, di-sodium hydrogen phosphate dehydrate, or sodium dihydrogen phosphate dehydrate;
- (v) 0.1 to 3.0 mg/mL of one or more stabilizers selected from alanine, valine, leucine, serine, threonine, lysine, histidine, tryptophan, aspartic acid, or glutamic acid;
- and
- (vi) 0.05% (v/v) to 2.5% (v/v) of one or more surfactants selected from polysorbates or nonoxynols;
- wherein the liquid composition is not reconstitution from a lyophilized or freeze-dried form by a physician prior to administration;
- and
- wherein the LD50 unit value is determined using a gelatine phosphate buffer.
Dependencies are inferred from the claim text.