# US 12,758,498 B2 · Topical gel formulation for skin and mouth disorders and a process of preparation thereof

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- Number: US 12,758,498 B2
- Document ID: US12758498B2
- Status: Granted
- Kind: B2
- Application number: 18/720,669
- Filed: 2022-12-16
- Published: 2025-02-13
- Granted: 2026-10-13
- Earliest claimed: 2021-12-17
- Applicants: Ramakrishna Devarakonda; Ashok Chandra Illapakurthy
- Inventors: Ramakrishna Devarakonda; Ashok Chandra Illapakurthy
- Web page: https://patentgrep.com/patent/US12758498B2

## CPC

- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61P 1/02: Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention relates to a formulation of topical or oromucosal gel for the treatment of disorders of skin and mouth. The formulation comprises misoprostol 1% dispersion, mineral oil, PEG 400-Part I. PEG 400-Part II and PEG 3350. The invention discloses formulations of two gels comprising 100 ug/g of misoprostol drug corresponding to a concentration of 0.01% and 30 ug of misoprostol drug corresponding to a concentration of 0.003% respectively. The formulation is effective against oral mucositis. RAS, diabetes foot ulcers, decubitus ulcers and skin burns. The animal studies indicate reduction of oral mucositis upon administration of the drug along with decrease in levels of biomarkers IL-6 and TNF-α and the body weight has been significantly maintained which indicate the drug to be safe and effective.

## Claims

### Claim 1

A topical or oromucosal gel formulation for treatment of skin and mouth disorders, the formulation comprising:
a) a misoprostol dispersion at a concentration range of 0.003%-0.01% (w/w);
b) a mineral oil at a concentration of 10% (w/w);
c) a polyethylene glycol (PEG) 400 Part I at a concentration of 10% (w/w);
d) a PEG 400 Part II at a concentration range of 26.44%-66.44% (w/w);
e) a PEG 3350 at a concentration range of 12.56%-52.56% (w/w).

### Claim 2 (depends on 1)

The topical or oromucosal gel formulation as claimed in claim 1, wherein said skin and mouth disorders are oral mucositis, Recurrent aphthous stomatitis (RAS), diabetes foot ulcers, decubitus ulcers and skin burns.

### Claim 3 (depends on 1)

The topical or oromucosal gel formulation as claimed in claim 1, wherein said topical or oromucosal gel formulation reduces the concentration of inflammatory biomarkers Tumor Necrosis Factor-α (TNF-α) and Interleukin-6 (IL-6) in serum and tongue of mouse.

### Claim 4 (depends on 1)

The topical or oromucosal gel formulation as claimed in claim 1, wherein said topical or oromucosal gel formulation is packaged into crimp sealed aluminum tubes.

### Claim 5

A process of preparation of topical or oromucosal gel formulation, the process comprising the steps of:
a) measuring 0.003%-0.01% (w/w) of misoprostol, 10% (w/w) of mineral oil, 10% (w/w) of PEG 400 Part-I, 26.44%-66.44% (w/w) of PEG 400 Part-II, and 12.56%-52.56% (w/w) of PEG 3350;
b) dispersing 0.003%-0.01% (w/w) misoprostol in PEG 400 Part-I and stirring to obtain a clear solution;
c) subjecting PEG 3350 to heating;
d) subjecting mineral oil and PEG 400 Part-II separately to heating;
e) mixing mineral oil and PEG 400 Part-II and PEG 3350 with constant stirring; and
f) subjecting misoprostol-PEG 400 Part-I solution and mineral oil-PEG mixture to constant stirring.

### Claim 6 (depends on 5)

The process as claimed in claim 5, wherein said PEG 3350 is heated to a temperature of 70° C.

### Claim 7 (depends on 5)

The process as claimed in claim 5, wherein said mineral oil and PEG 400 Part-II are heated to a temperature of 70° C.

### Claim 8 (depends on 5)

The process as claimed in claim 5, wherein subjecting said mineral oil and PEG 400 Part-II to separate heating to enhance the miscibility with PEG 3350.

### Claim 9 (depends on 5)

The process as claimed in claim 5, wherein said PEG 400 Part-II and PEG 3350 are stirred maintaining a temperature range of 40° C.-45° C.