# US 10,383,826 B2 · Apparatus and process for encapsulating capsules or other solid dosage forms within capsules

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- Number: US 10,383,826 B2
- Document ID: US10383826B2
- Status: Granted
- Kind: B2
- Application number: 15/256,709
- Filed: 2016-09-05
- Published: 2017-04-06
- Granted: 2019-08-20
- Earliest claimed: 2010-07-19
- Assignees: Procaps SA
- Applicants: Carlos Salazar Altamar; Gustavo Anaya; Braulio Teran; Newman Aguas Navarro; Wilmer Herrera
- Inventors: Carlos Salazar Altamar; Gustavo Anaya; Braulio Teran; Newman Aguas Navarro; Wilmer Herrera
- Web page: https://patentgrep.com/patent/US10383826B2

## CPC

- A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)}
- A61J 3/07: into the form of capsules or similar small containers for oral use
- A61J 7/0076: {Medicament distribution means (with pill counting devices A61J7/02; with time indication A61J7/04; containers or packages with special means for dispensing contents B65D83/00)}
- A61K 9/4833: {Encapsulating processes; Filling of capsules (mechanical aspects A61J3/07)}
- A61K 31/60: Salicylic acid; Derivatives thereof
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 3/06: Antihyperlipidemics
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14)
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- B65D 83/04: for dispensing annular, disc-shaped, spherical or like small articles, e.g. tablets or pills
- 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)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES

## Abstract

The present invention provides an apparatus and process for making softgel capsules having incorporated therein other solid dosage forms selected from the group consisting of pellets, smaller capsules, smaller tablets, sustained release solid dosage forms, immediate release solid dosage forms, extended release solid dosage forms and zero order release solid dosage forms, said apparatus comprising: (a) two spreader boxes; (b) two casting drums; (c) a pair of rotary dies having means for suction; (d) a liquid fill system; (e) a wedge for heating gelatine ribbons and feeding said fill; and (f) two lateral dispensing devices said lateral dispensing devices including hoppers having said solid dosage forms, channel guides for transporting said solid dosage forms and a grasping claw for dispensing said solid dosage form into the softgel pocket formed in the rotary dies.

## Claims

### Claim 1

A method for making softgel capsules having incorporated within said capsules one or more smaller solid forms wherein said solid forms are not compatible with each other or with another active in the softgel capsule, said method comprising:
(a) casting a gel forming composition to make films;
(b) passing said films through a pair of rotary dies having vacuum means to make pockets;
(c) feeding via guide channels said smaller solid forms into said pockets using a lateral dispensing and feeding system that uses grasping claws; each grasping claw having volume capacity for grasping a fixed dose of the smaller solid form coming through one of said channel guides and configured for releasing the fixed dose into a half pocket of the softgel;
(d) filling said softgel pockets with a medicine formulation in liquid form via a wedge segment; and
(e) forming said capsule by sealing the pockets together.

### Claim 2

A process for making a softgel capsule having incorporated within said capsules one or more smaller capsules wherein said smaller capsules have active ingredients that are not compatible with each other or with another active in the softgel capsule, said method comprising:
(a) feeding film sheets between a first die roll and a second die roll wherein each of the die rolls have softgel capsule pockets in a plurality of rows and said softgel capsule pockets have at least one orifice for application of suction;
(b) applying suction while said film is in place in the softgel capsule pockets;
(c) feeding via guide channels through a lateral dispensing device having a hopper and grasping claws; each grasping claw having volume capacity for grasping a fixed dose of the smaller capsules coming through one of said channel guides and configured for releasing the fixed dose into a half pocket of the softgel; preformed smaller capsules onto the film sheets overlying the die rolls at positions having the capsule pockets;
(d) filling said softgel capsule pockets also via a wedge segment with a liquid medical formulation; and
(e) cutting the film sheets about the softgel capsule pockets to form said softgel capsules having smaller capsules in combination with a suitable liquid pharmaceutical combination.