Pharmaceutical composition for a sustained release of lanreotide
A pharmaceutical composition for a sustained release of peptide therapeutics, in particular for a sustained release compatible with therapeutic treatments of at least two months. In an embodiment, the composition comprises lanreotide as an active agent, a hydrosoluble co-solvent, and water with the pH of the composition being from 4.0 to 7.5.
1. A pharmaceutical composition consisting of:
lanreotide, present at a concentration of from 42% to 46% of the total weight of the composition;
one or more glycofurols of formula (I),
wherein n is an integer from 1 to 5; and
wherein the one or more glycofurols is present at a concentration of from 16% to 20% of the total weight of the composition;
acetic acid;
an additive selected from a stabilizer, an antioxidant, and/or a surfactant, wherein the additives is present in an amount of from 0 to 5% of the total weight of the composition; and
water (q.s. 100%);
wherein the pH of the composition is from 4.0 to 6.0.
2. The composition of claim 1 , wherein the pH of the composition is from 4.8 to 5.4.
3. The composition of claim 1 , wherein the total amount of additive in the composition is less than 1% of the total weight of the composition.
4. A method of treating acromegaly or a neuroendocrine tumor, the method comprising administering a therapeutically-effective amount of the composition of claim 1 to a patient in need thereof.
5. The method according to claim 4 wherein the composition is administered parenterally.
6. The composition of claim 1 , wherein lanreotide is in salt form.
7. The composition of claim 1 , wherein lanreotide is in the form of lanreotide acetate.