# US 11,433,007 B2 · Powdered compositions based on polyhydroxyalkanoates and uses thereof in dental prophylaxes

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- Number: US 11,433,007 B2
- Document ID: US11433007B2
- Status: Granted
- Kind: B2
- Application number: 17/253,030
- Filed: 2019-06-24
- Published: 2021-04-22
- Granted: 2022-09-06
- Earliest claimed: 2018-06-27
- Assignees: Bio-On S.P.A.
- Applicants: BIO-ON S.p.A.
- Inventors: Antonino Ferraro; Paolo Saettone; Mauro Comes Franchini
- Web page: https://patentgrep.com/patent/US11433007B2

## CPC

- A61K 8/022: {Powders; Compacted Powders}
- A61K 6/20: Protective coatings for natural or artificial teeth, e.g. sealings, dye coatings or varnish
- A61K 8/25: Silicon; Compounds thereof
- A61K 8/345: {containing more than one hydroxy group}
- A61K 8/44: Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
- A61K 8/85: Polyesters
- A61K 31/745: Polymers of hydrocarbons
- A61Q 11/00: Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
- A61K 2800/28: Rubbing or scrubbing compositions; Peeling or abrasive compositions; Containing exfoliants
- A61K 2800/412: Microsized, i.e. having sizes between 0.1 and 100 microns
- A61K 2800/805: Corresponding aspects not provided for by any of codes A61K2800/81 - A61K2800/95
- 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)
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

Powdered composition comprising: (a) 100 parts by weight of at least one polyhydroxyalkanoate (PHA) in the form of particles having an average diameter (d50) from 1 μm to 100 μm, preferably from 5 μm to 60 μm; (b) from 0.1 to 10 parts by weight, preferably from 0.5 to 5 parts by weight, of at least one silicate or silica. The powdered composition, having a relatively low abrasivity index and high flowability, can be used in air-polishing without causing excessive abrasion of the enamel and of the root cementum and without causing sticking in the device. Furthermore, the presence of PHA, being a polymer characterized by high biodegradability, makes the powdered composition particularly suitable for use in the oral cavity.

## Claims

### Claim 1

A powdered composition, comprising:
(a) 100 parts by weight of at least one polyhydroxyalkanoate (PHA) in a form of particles having an average diameter (d50) greater than or equal to 1 micron (μm) and less than or equal to 100 μm: and
(b) greater than or equal to 0.1 parts by weight and less than or equal to 10 parts by weight of at least one silicate or at least one silica.

### Claim 2 (depends on 1)

The powdered composition of claim 1, wherein the at least one PHA is in the fou ii of particles having substantially spherical shape and a polydispersity index (span) greater than or equal to 1.0 and less than or equal to 2,
where the span is a ratio (d90-d10)/d50,
where d90 is a diameter value below which 90% by weight of a population of the particles is found,
where d10 is the diameter value below which 10% by weight of the population of the particles is found, and
where d50 is the diameter value below which 50% by weight of the particle population of the particles is found (median value).

### Claim 3 (depends on 1)

The powdered composition of claim 1, wherein the at least one PHA is selected from: polyhydroxybutyrate (PHIS), polyhydroxybutyrate-hydroxyvalerate copolymer, or a mixture thereof.

### Claim 4 (depends on 1)

The powdered composition of claim 1, wherein the at least one silica is selected from: pyrogenic silica or colloidal silica.

### Claim 5 (depends on 1)

The powdered composition of claim 1, wherein the at least one silicate is selected from:
phyllosilicatesor or hydroxysilicates.

### Claim 6 (depends on 1)

The powdered composition of claim 1, wherein the at least one silicate or the at least one silica is in a form of particles having an average diameter (d50) greater than or equal to 1 in and less than or equal to 50 μm.

### Claim 7 (depends on 1)

The powdered composition of claim 1, wherein the at least one silica comprises hydrophobic silica.

### Claim 8 (depends on 1)

The powdered composition of claim 1, further comprising an additional component selected from:
calcium phosphate, calcium carbonate, calcium bicarbonate, fluorinated salts, or mixtures thereof.

### Claim 9 (depends on 8)

The powdered composition of claim 8, wherein the additional component is present in an amount greater than or equal to 5 parts by weight and less than or equal to 90 parts by weight.

### Claim 10 (depends on 1)

The powdered composition of claim 1, further comprising:
greater than or equal to 0.1 parts by weight and less than or equal to 10 parts by weight of at least one sulfate of metal selected from: alkali metals, alkaline earth metals, or aluminum.

### Claim 11 (depends on 1)

The powdered composition of claim 1, having a flow index, determined by the “flow through an orifice” method described in chapter 2.9.36 of the European Pharmacopoeia (IX Edition of 1 Jan. 2017), less than or equal to 20.

### Claim 12 (depends on 1)

The powdered composition of claim 1, further comprising:
greater than or equal to 0.1 parts by weight and less than or equal to 5 parts by weight of at least one flavoring.

### Claim 13 (depends on 1)

The powdered composition of claim 1, further comprising:
an additional abrasive component selected from: sodium bicarbonate, glycine, or erythritol, in an amount greater than or equal to 1 part by weight and less than or equal to 50 parts by weight.

### Claim 14 (depends on 1)

The powdered composition of claim 1, further comprising:
at least one adjuvant additive selected from: hemostatic agents, antimicrobial agents, bleaching agents, soothing agents, gum revitalizers, or dyes.

### Claim 15 (depends on 1)

The powdered composition of claim 1, wherein the at least one PHA in the form of particles is obtained from aqueous suspension of the at least one PHA using an atomization (spray drying) process.

### Claim 16 (depends on 1)

A method of dental prophylaxis, the method comprising: air-polishing teeth using the powdered composition of claim 1.

### Claim 17 (depends on 16)

The method of claim 16, wherein the teeth are human teeth.

### Claim 18 (depends on 16)

The method of claim 16, wherein the teeth are other than human teeth.

### Claim 19

A powdered composition, comprising:
(a) 100 parts by weight of at least one polyhydroxyalkanoate (PHA) in a form of particles having an average diameter (d50) greater than or equal to 5 microns (μm) and less than or equal to 60 μm; and
(b) greater than or equal to 0.1 parts by weight and less than or equal to 10 parts by weight of at least one silicate or at least one silica.

### Claim 20

A powdered composition, comprising:
(a) 100 parts by weight of at least one polyhydroxyalkanoate (PEIA) in a form of particles having an average diameter (d50) greater than or equal to 1 micron (μm) and less than or equal to 100 μm; and
(b) greater than or equal to 0.5 parts by weight and less than or equal to 5 parts by weight of at least one silicate or at least one silica.
