Method for manufacturing a dispensing device for eye drops

• US 10,442,583 B2
• Filed: 04/07/2016
• Issued: 10/15/2019
• Est. Priority Date: 04/10/2015
• Status: Active Grant

• Current Assignee: Dompe Farmaceutici S.p.A (Sergio Dompé SRL)
• Original Assignee: Dompe Farmaceutici S.p.A (Sergio Dompé SRL)
• Inventors: Gentile, Marco Maria
• Primary Examiner(s): Cozart, Jermie E
• Application Number:
  US15/564,286
• Publication Number:
  US 20180134468A1
• Time in Patent Office: 1,286 Days
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: B21D 53/00 Making other particular articles making wire fabrics B21F; making chains or chain parts B21L
• CPC Class Codes: B65B 3/04 Methods of, or means for, filling the material into the containers or receptacles
• CPC Class Codes: B65D 47/18 for discharging drops; Droppers droppers in general B01L3/00; pipettes connected to container closures B01L3/0282
• CPC Class Codes: B65D 81/3211 coaxially and provided with means facilitating admixture
• CPC Class Codes: B65D 81/3216 Rigid containers disposed one within the other
• CPC Class Codes: B65D 81/3227 arranged parallel or concentrically and permitting simultaneous dispensing of the two materials without prior mixing B65D81/325 takes precedence
• CPC Class Codes: F26B 25/063 Movable containers or receptacles, e.g. carts, trolleys, pallet-boxes for use in freeze-drying apparatus F26B5/06; in general B62D
• CPC Class Codes: F26B 5/065 the product to be freeze-dried being sprayed, dispersed or pulverised
• CPC Class Codes: Y10T 29/53343 including fluid component

Abstract

A process for the production of a device for dispensing eye drops. The process includes the steps of providing a first container and a second container configured to be engaged in a fluid-tight manner, providing a spacer, introducing a water-based solution inside the first container, introducing a solution or dispersion comprising a drug inside the second container, arranging the spacer between the first and second containers, engaging in a fluid-tight manner the second container and the first container, and freeze-drying the solution or dispersion comprising the drug.

Claims

1. Process for production of a device for dispensing eye drops, comprising steps of:

providing a first container comprising a tubular element with an open end portion;

providing a second container comprising a wall engageable in a fluid-tight manner around the tubular element;

providing a spacer having oppositely arranged bases which are substantially parallel;

introducing water or a water-based solution for injection inside the first container;

introducing a solution or a dispersion comprising a drug of one or more of a chemical and biotechnological nature inside the second container;

arranging the spacer between the first and second containers so that the bases are in contact with the first and second containers;

engaging in a fluid-tight manner the wall of the second container around the tubular element of the first container; and

freeze-drying the solution or the dispersion comprising the drug;

wherein the step of freeze-drying the solution or the dispersion comprising the drug is performed following assembly of the first and second containers with the spacer and comprises subjecting the assembly of the first container and the second container and the spacer to a freeze-drying atmosphere.

2. The process according to claim 1, further comprising steps of providing a dispensing member and engaging the dispensing member with the second container.

3. The process according to claim 2, wherein the dispensing member is a dropper.

4. The process according to claim 2, wherein the step of engaging the dispensing member with the second container is performed in a sterile environment and is performed following the step of freeze-drying the solution or the dispersion comprising the drug.

5. The process according to claim 4, further comprising a step of packaging the eye-drop dispensing device in one or more of a sterile and hermetically sealed container, the packaging step being performed following the step of engaging the dispensing member with the second container and being performed in a nitrogen-containing atmosphere.

6. The process according to claim 1, wherein the drug of the one or more chemical and biotechnological nature comprises a nerve growth factor (NGF).

7. The process according to claim 1, wherein the second container comprises a collar with an opening and a base portion defining a seat, the seat being delimited at one end by a piercible barrier and being delimited laterally by said wall of the second container, the assembly step comprising engaging the tubular element of the first container in a fluid-tight manner inside the seat, the step of subjecting the assembly to the freeze-drying atmosphere being performed so as to cause a water content of the solution or the dispersion comprising the drug to flow out from the opening of the collar obtaining a freeze-dried composition comprising the drug and so as to freeze the water or the water-based solution for injection, the water or the water-based solution for injection freezing without coming out of the seat so that, following removal of the assembly from the freeze-drying atmosphere, the water or the water-based solution for injection becomes liquid again.

8. The process according to claim 7, wherein the second container comprises a piercible barrier designed to separate substances intended to be contained inside the first container and the second container, the process comprising further a multidose eye drop solution preparing step comprising the steps of:

removing the spacer;

piercing the barrier using said tubular element;

mixing together the water or the water-based solution for injection and the freeze-dried composition comprising the drug following the freeze-drying step so as to obtain an eye solution.

9. The process according to claim 1, comprising at least one step for sterilization of one or more of at least one of the first and second containers, the spacer, and the dispensing member, the sterilization being of a type using gamma rays or of a type using ethylene oxide or of a type performed using steam in an autoclave.

10. The process according to claim 9, wherein said at least one sterilization step is performed between assembly of the first and second containers with the spacer and the step for freeze-drying the solution or the dispersion comprising the drug.

11. The process according to claim 9, wherein said at least one sterilization step is performed before introducing the water or the water-based solution for injection and introducing the solution or the dispersion comprising the drug, respectively inside the first and second containers.

12. The process according to claim 1, wherein the second container comprises a piercible barrier and a base portion defining a seat delimited at one end by the piercible barrier and delimited laterally by the wall of the second container and being fluid tight, assembly of the first and second containers with the spacer further comprising step of engaging the tubular element of the first container inside the fluid-tight seat on said wall of the second container so that the open end portion of the tubular element is positioned facing the piercible barrier.

13. The process according to claim 1, wherein assembly of the first and second containers with the spacer further comprises steps of:

engaging the spacer with the first container; and

engaging the second container with assembly of the first container and the spacer;

the first container comprising a base portion comprising a substantially flat support base and an opposite wall parallel to the support base and the tubular element projecting transversely from said opposite wall, the step of engaging the spacer with the first container comprising positioning the spacer around the tubular element and close to or in contact with said opposite wall; and

the second container comprising a piercible barrier and a base portion defining a seat delimited at one end by the piercible barrier and delimited laterally by the wall of the second container, the step of engaging the second container with the assembly of the first container and the spacer comprising positioning the tubular element inside the seat in a fluid-tight manner on said wall of the second container.

14. The process according to claim 13, wherein the tubular element comprises means for mechanically connecting together the first container and the second container, and wherein the step of engaging the second container with the assembly of the first container and the spacer comprising engaging the second container with the first container using said means for mechanically connecting.