Dual-chamber pack

Patent metadata

Field	Value
Publication number	US-10285908-B2
Application number	US-201515329070-A
Country	US
Kind code	B2
Filing date	Jul 30, 2015
Priority date	Jul 30, 2014
Publication date	May 14, 2019
Grant date	May 14, 2019

Abstract

The present invention relates to a dual-chamber pack for a multi-dose oral liquid pharmaceutical composition wherein the compositions of the first and second chambers are mixed at the time of first administration.

First claim

We claim:

1. A dual-chamber pack for a multi-dose oral liquid pharmaceutical composition comprising of:
(a) a first chamber in the form of a container ( 8 ) provided with an opening ( 7 ) at an upper end, comprising a liquid vehicle containing one or more pharmaceutically acceptable inert excipients; and
(b) a second chamber comprising:
(i) a plunger ( 3 ) adapted to fit into a plug ( 4 ) having a top flat surface, containing a solid composition comprising a drug in an amount of from about 50 mg to about 130 g and one or more pharmaceutically acceptable inert excipients; and
(ii) a plug ( 4 ), with a breakable polymeric membrane ( 5 ), adapted to fit into the opening ( 7 ) from a lower end and into a cap ( 1 ) from the upper end; and
(c) the cap ( 1 ) over the second chamber comprising a means to exert pressure onto the plunger ( 3 ) so as to partially rupture the breakable polymeric membrane ( 5 ) of the plug ( 4 ) and deliver the solid composition into the container ( 8 )
wherein the compositions of both chambers are mixed at the time of first administration by applying pressure on the cap ( 1 ) and the plunger ( 3 ) is activated by a screw-based mechanism and the reconstituted oral liquid pharmaceutical composition formed after mixing for first administration is stable at 40° C. and 75% RH for a period of at least 1 month.

2. The dual-chamber pack according to claim 1 , wherein the liquid vehicle is present in an amount of from about 5 mL to about 350 mL.

3. The dual-chamber pack according to claim 1 , wherein the solid composition of the second chamber is in the form of a powder, a paste, beads, granules, gel, or a compressed tablet.

4. The dual-chamber pack according to claim 1 , wherein the multi-dose oral liquid pharmaceutical composition is in the form of a suspension or a syrup dosage form.

5. The dual-chamber pack according to claim 1 , wherein the plug ( 4 ) may be screwed or snuggly fitted onto the opening ( 7 ) of the container ( 8 ).

6. The dual-chamber pack according to claim 1 , wherein the plunger ( 3 ) may be flute shaped or may exhibit two or more sharp projections.

7. The dual-chamber pack according to claim 1 , wherein the plunger ( 3 ) is inversely fitted into the plug ( 4 ) and the plug ( 4 ) is then mounted on the opening ( 7 ) of the container ( 8 ).

8. The dual-chamber pack according to claim 1 , wherein not more than three-fourths of the circumference of the polymeric membrane ( 5 ) is ruptured by the plunger ( 3 ) when pressure is applied on the cap ( 1 ).

9. The dual-chamber pack according to claim 1 , wherein the cap ( 1 ) further comprises a tamper-evident tear band ( 2 ).

Assignees

• Sun Pharmaceutical Ind Ltd
• Sun Pharmaceutical Ind Ltd

Inventors

• Mittal Bhupesh Kumar
• Pardal Neha

Classifications

• B65D51/2835

  ruptured by a sharp element, e.g. a cutter or a piercer · CPC title

• A61J7/0046

  Cups, bottles or bags · CPC title

• B65D41/34

  Threaded or like caps or cap-like covers {provided with tamper elements formed in, or attached to, the closure skirt} · CPC title

• A61J1/2093 Primary

  Containers having several compartments for products to be mixed · CPC title

• B65D51/285

  ruptured by a sharp element, e.g. a cutter or a piercer · CPC title