# US 11,304,910 B2 · Soft gelatin capsules with pH-independent release

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- Number: US 11,304,910 B2
- Document ID: US11304910B2
- Status: Granted
- Kind: B2
- Application number: 15/781,708
- Filed: 2016-11-25
- Published: 2018-12-13
- Granted: 2022-04-19
- Earliest claimed: 2015-12-09
- Assignees: Altergon S.A.
- Applicants: Altergon S.A.
- Inventors: Simone Carucci; Maurizio Marchiorri; Marco Pontiggia; Tiziano Fossati
- Web page: https://patentgrep.com/patent/US11304910B2

## CPC

- A61K 9/4825: {Proteins, e.g. gelatin (gelatin capsule shells with substantial amounts of other macromolecular substances A61K9/4816)}
- A61K 9/4866: {Organic macromolecular compounds}
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/02: Inorganic compounds
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/40: Cyclodextrins; Derivatives thereof
- 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

Disclosed are soft gelatin capsules comprising a gelatin shell, a plasticiser, water, and optionally a calcium salt and a filling containing a dispersed or solubilised medicament comprising gelatin with gelling power, hydrolysed gelatin, glycerol, water, pectin and gellan gum. The formulations according to the invention allow gradual release of the active ingredient, regardless of pH.

## Claims

### Claim 1

A soft gelatin capsule, wherein the capsule comprises
a shell containing gelatin, a plasticizer, water and a calcium salt and
a filling,
wherein the filling contains a medicament dispersed or solubilised in a hydrophilic filling comprising from 1 to 5% of gelatin having a Bloom value ranging from 60 to 150 in percentages, said gelatin having gelling power, from 10 to 30% of hydrolyzed gelatin, from 10 to 30% of 85% glycerol, from 20 to 60% water, from 10 to 30% of pectin, up to 5% of gellan gum and from 0.1 to 10% of alcohol, the percentages being expressed by weight, on the total filling weight, wherein said soft gelatin capsule allows, in vitro, releasing of said medicament in a sustained pH-independent manner, said releasing beginning at the release time of said medicament and continuing for up to 360 minutes.

### Claim 2 (depends on 1)

A capsule according to claim 1 wherein the medicament can be dispersed or solubilised by means of ethanol or other hydrophilic or lipophilic solvents, and/or complexed with cyclodextrin.

### Claim 3 (depends on 1)

A capsule according to claim 1 wherein the shell contains calcium chloride.

### Claim 4 (depends on 1)

A capsule according to claim 1, wherein the medicament is selected from non-steroidal anti-inflammatory drugs, thyroid hormones, statins, bronchodilators, antihistamines, steroids, narcotic analgesics, antibacterials/antivirals, vitamins, oils of various kinds, glycosaminoglycans, antimycotics, proton pump inhibitors, fertility hormones, corticosteroids, erectile dysfunction medicaments, and anticoagulants.

### Claim 5 (depends on 1)

A capsule according to claim 1 wherein the she contains from 20 to 45% of gelatin having a Bloom value ranging from 110 to 300, plasticizer from 15 to 30%, water from 30 to 40% and a calcium salt, the percentages being on the total shell weight.

### Claim 6 (depends on 5)

A capsule according to claim 5 wherein the calcium salt is calcium chloride.

### Claim 7 (depends on 6)

A capsule according to claim 6 wherein calcium chloride is present in percentages by weight ranging from 0.5 to 5% on the total shell weight.

### Claim 8 (depends on 1)

A capsule according to claim 1, wherein the plasticizer is selected from anhydrous glycerol, sorbitol, sorbitol/sorbitan mixtures, 1,2 propylene glycol, macrogol 200-600 and mixtures thereof.

### Claim 9 (depends on 8)

A capsule according to claim 8 wherein the plasticizer is anhydrous glycerol.