# US 2017/0281584 A1 · Misoprostol Dispersible Tablet

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- Number: US 2017/0281584 A1
- Document ID: US20170281584A1
- Status: Published application
- Kind: A1
- Application number: 15/625,194
- Filed: 2017-06-16
- Published: 2017-10-05
- Earliest claimed: 2014-07-11
- Assignees: Azanta Danmark A/S
- Applicants: Azanta Danmark A/S
- Inventors: Selvaraj SEKAR; Elumalai BASKAR; Arunachalam MALAIARASAN; Venugopal PRABHAKARAN
- Web page: https://patentgrep.com/patent/US20170281584A1

## CPC

- A61K 31/215: of carboxylic acids
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 9/2027: {obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates}
- A61K 9/2054: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2059: {Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin}
- A61K 31/5575: having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
- A61K 2121/00: Preparations for use in therapy
- 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)

## Abstract

The present invention relates to a solid pharmaceutical formulation comprising misoprostol or a pharmaceutically acceptable salt thereof. In particular, the invention relates to a dispersible tablet comprising misoprostol or a pharmaceutically acceptable salt thereof.

## Claims

### Claim 1

A pharmaceutical dosage form comprising misoprostol, or a pharmaceutically acceptable salt thereof, as the sole active ingredient, and at least a first disintegrant;
wherein the dosage form is suitable for use in a treatment comprising cervical ripening or the induction of labor upon administration to a subject;
wherein the dosage form has a content of 0.5-50 μg misoprostol, or an equivalent amount of pharmaceutically acceptable salt thereof
wherein the dosage form is suitable for sublingual or oral administration; and
wherein the dosage form disperses in 100 ml water at 25° C. within 3 minutes upon stirring, thereby providing a dispersion that passes through a sieve screen with a nominal mesh aperture of 710 μm.

### Claim 2 (depends on 1)

The pharmaceutical dosage form according to claim 1 that is suitable for sublingual administration.

### Claim 3 (depends on 1)

The pharmaceutical dosage form according to claim 1, wherein the first disintegrant is cross-linked polyvinylpyrrolidone (PVP).

### Claim 4 (depends on 1)

The pharmaceutical dosage form according to claim 1, further comprising a second disintegrant.

### Claim 5 (depends on 4)

The pharmaceutical dosage form according to claim 4, wherein the first and second disintegrants are cross-linked PVP and crospovidone.

### Claim 6 (depends on 4)

The pharmaceutical dosage form according to claim 4, wherein at least one of said first and second disintegrants is a cross-linked carboxymethylcellulose.

### Claim 7 (depends on 4)

The pharmaceutical dosage form according to claim 4, wherein at least one of said first and second disintegrants is croscarmellose sodium.

### Claim 8 (depends on 4)

The pharmaceutical dosage form according to claim 4, wherein the first and second disintegrants use different mechanisms of disintegration.

### Claim 9 (depends on 4)

The pharmaceutical dosage form according to claim 4, wherein the first and second disintegrants use mechanisms of disintegration selected from the group consisting of swelling, porosity and capillary action, and deformation.

### Claim 10 (depends on 1)

The pharmaceutical dosage form according to claim 1, wherein the first disintegrant is starch.

### Claim 11 (depends on 1)

The pharmaceutical dosage form according to claim 1, wherein the first disintegrant is present in an amount of 1-50% by weight.

### Claim 12 (depends on 11)

The pharmaceutical dosage form according to claim 11, wherein the first disintegrant is crospovidone.

### Claim 13 (depends on 1)

The pharmaceutical dosage form according to claim 1, further comprising starch in amount of 1-50% by weight.

### Claim 14 (depends on 13)

The pharmaceutical dosage form according to claim 13, wherein the starch is maize starch.

### Claim 15 (depends on 1)

The pharmaceutical dosage form according to claim 1, wherein the content of misoprostol, or an equivalent amount of pharmaceutically acceptable salt thereof, is 5-50 μg.

### Claim 16 (depends on 1)

The pharmaceutical dosage form according to claim 1, having a disintegration time of less than 2 minutes.

### Claim 17 (depends on 16)

The pharmaceutical dosage form according to claim 16, having a disintegration time of less than 20 seconds.

### Claim 18 (depends on 1)

The pharmaceutical dosage form according to claim 1 that disperses in 100 ml water at 25° C. within 1 minute upon stirring, thereby providing a dispersion that passes through a sieve screen with a nominal mesh aperture of 710 m.