JPWO2021019092A5 - - Google Patents

Claims (9)

1-1.5% by weight of clindamycin phosphate, 2.5-3.5% by weight of benzoyl peroxide, and 0.1-0.2% by weight of adapalene as a gelling agent, polyvalent Topical gel formulations, including in combination with alcohol and water. 2. The topical gel formulation of claim 1, comprising about 1.2% by weight clindamycin phosphate, about 3.1% by weight benzoyl peroxide, and about 0.15% by weight adapalene. the formulation is
a. about 1.2% by weight of clindamycin phosphate;
b. about 3.1% by weight of benzoyl peroxide;
c. about 0.15% by weight of adapalene;
d. about 5% by weight of propylene glycol;
e. about 1.75% by weight of carbomer homopolymer type C;
f. Potassium hydroxide in an amount to provide a pH of 5-6, and
g. water,
3. The topical gel formulation of claim 2, comprising: A topical gel formulation according to any one of claims 1 to 3 for treating acne vulgaris or acne in a patient in need thereof. 5. The topical gel formulation of claim 4, which is administered to the patient's affected area at least once a day. 6. The topical gel formulation of claim 4 or 5, administered to the patient's affected area once daily for at least 4 weeks, including at least 12 weeks. The treatment comprises (i) 1-1.5 wt% clindamycin phosphate and 2.5-3.5 wt% benzoyl peroxide, (ii) 2.5-3.5 wt% excess from benzoyl oxide and 0.1-0.2% by weight adapalene and (iii) 1-1.5% by weight clindamycin phosphate and 0.1-0.2% by weight adapalene 7. The topical gel formulation of claim 4, 5, or 6, which is more effective in treating acne than treatment with a formulation containing the selected active ingredient. A pharmaceutical product comprising a container provided with a pump and a topical gel formulation according to any one of claims 1 to 7, the pump being adjusted to release a specific amount of the formulation each time the pump is pressed. Pharmaceuticals. A method for producing a topical gel formulation according to any one of claims 1 to 7,
i. Premixes for:
a) a premix A comprising a gelling agent dispersed in water,
b) Premix B, comprising polyhydric alcohol and benzoyl peroxide dispersed in water,
c) Premix C, containing an aqueous solution of clindamycin phosphate,
d) providing a premix D comprising micronized adapalene dispersed in a polyhydric alcohol and water;
ii. mixing premix A and premix D;
iii. mixing premix B into the mixture of step ii;
iv. mixing premix C into the mixture of step iii;
v. adjusting the pH of the mixture of step iv to pH 5-6 to form a gel;
A method, including