# US 10,245,232 B2 · Crystalline microspheres and the process of manufacturing the same

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- Number: US 10,245,232 B2
- Document ID: US10245232B2
- Status: Granted
- Kind: B2
- Application number: 14/809,362
- Filed: 2015-07-27
- Published: 2016-01-21
- Granted: 2019-04-02
- Earliest claimed: 2012-04-25
- Assignees: SPI Pharma, Inc.
- Applicants: SPI Pharma, Inc.
- Inventors: Cecil W. Propst; Marc W. Meadows; Michael S. Todd
- Web page: https://patentgrep.com/patent/US10245232B2

## CPC

- A61K 9/1623: {Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules}
- A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)}
- Y10T 428/2982: Particulate matter [e.g., sphere, flake, etc.]
- 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)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Microspheres comprising a core material, wherein the microspheres have a circularity greater than 0.95 and an aspect ratio greater than 0.95, and methods of manufacturing the same. The microspheres may be useful in the manufacture of sustained and modified release active pharmaceutical ingredient (API) microspheres, as a free flowing excipient for mini-tablets and in the manufacture of API dispersions.

## Claims

### Claim 1

A microsphere comprising a core material, wherein the microsphere has a circularity greater than 0.95 and an aspect ratio of shortest diameter to longest diameter that is greater than 0.95, wherein the microsphere has a skeletal density from about 1.4595 g/cc to about 1.4651 g/cc, and wherein the microsphere has a moisture gain of less than 1.0% at 90% relative humidity.

### Claim 2 (depends on 1)

The microsphere of claim 1, wherein the microsphere has a mean particle size from about 10 μm to about 500 μm.

### Claim 3 (depends on 2)

The microsphere of claim 2, wherein the microsphere has a mean particle size from about 10 μm to about 20 μm.

### Claim 4 (depends on 3)

The microsphere of claim 3, wherein the microsphere has a moisture content of 0.5% or less.

### Claim 5 (depends on 1)

The microsphere of claim 1, wherein the microsphere has a particle size distribution of 2.8 or less.

### Claim 6 (depends on 5)

The microsphere of claim 5, wherein the microsphere has a particle size distribution of 2.0 or less.

### Claim 7 (depends on 5)

The microsphere of claim 5, wherein the microsphere has a particle size distribution of 1.5 or less.

### Claim 8 (depends on 5)

The microsphere of claim 5, wherein the microsphere has a particle size distribution of 1.0.

### Claim 9 (depends on 1)

The microsphere of claim 1, wherein the microsphere has a moisture content of 0.5% or less.

### Claim 10 (depends on 1)

The microsphere of claim 1, wherein the microsphere is water soluble.

### Claim 11 (depends on 1)

The microsphere of claim 1, wherein the microsphere comprises a single core material.

### Claim 12 (depends on 11)

The microsphere of claim 11, wherein the single core material is mannitol.

### Claim 13 (depends on 1)

The microsphere of claim 1, wherein the microsphere comprises a 100% crystalline core.

### Claim 14 (depends on 1)

The microsphere of claim 1, wherein the microsphere further comprises an active pharmaceutical ingredient.

### Claim 15 (depends on 1)

The microsphere of claim 1, wherein the core material is a polyol.

### Claim 16 (depends on 15)

The microsphere of claim 15, wherein the polyol is mannitol.

### Claim 17 (depends on 1)

The microsphere of claim 1, wherein the microsphere lacks internal voids.

### Claim 18 (depends on 1)

A composition comprising the microsphere of claim 1.

### Claim 19 (depends on 18)

The composition of claim 18, further comprising an active pharmaceutical ingredient.

### Claim 20 (depends on 1)

The microsphere of claim 1, wherein the microsphere lacks porosity.