WO2022003585A1 - Timbre transdermique de diclofénac et son procédé - Google Patents

Timbre transdermique de diclofénac et son procédé Download PDF

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Publication number
WO2022003585A1
WO2022003585A1 PCT/IB2021/055856 IB2021055856W WO2022003585A1 WO 2022003585 A1 WO2022003585 A1 WO 2022003585A1 IB 2021055856 W IB2021055856 W IB 2021055856W WO 2022003585 A1 WO2022003585 A1 WO 2022003585A1
Authority
WO
WIPO (PCT)
Prior art keywords
transdermal patch
adhesive
composition
under stirring
blend
Prior art date
Application number
PCT/IB2021/055856
Other languages
English (en)
Inventor
Srinivas Reddy MALE
Ganesh Haridas DOHE
Imran Ibrahim KAKATI
Shantaram Laxman PAWAR
Original Assignee
Hetero Healthcare Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hetero Healthcare Limited filed Critical Hetero Healthcare Limited
Publication of WO2022003585A1 publication Critical patent/WO2022003585A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds

Definitions

  • NuPatch Patch is marketed by Zydus Cadila. Each 37.5 cm patch contains 100 mg of Diclofenac diethylamine, Light mineral oil, Colloidal silicon dioxide, Polyisobutylene as pharmaceutically acceptable excipients.
  • Another embodiment of the present invention provides process for the preparation of Diclofenac diethylamine transdermal patch by using hot-melt coating technique (HMC) comprising the steps of melting, mixing, coating, laminating and cutting.
  • HMC hot-melt coating technique
  • transdermal patch composition comprising active ingredient having anti-inflammatory, analgesic and antipyretic activities.
  • the drug-adhesive blend was coated on Polyethylene terephthalate (75 micron) release liner maintaining coating temperature of 90°C to 100°C and laminated with Polyester 100% woven fabric one way stretchable (115 gms) backing membrane. The laminate was further cut into required patch size.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La présente invention concerne une composition de timbre transdermique comprenant un principe actif présentant des activités anti-inflammatoire, analgésique et antipyrétique. La présente invention concerne spécifiquement une composition de timbre transdermique comprenant du diclofénac comme principe actif, une concentration élevée d'adhésif sensible à la pression thermofusible, une faible concentration d'agent poisseux et des excipients pharmaceutiquement acceptables. La présente invention concerne également un procédé de préparation d'un timbre transdermique à base de diclofénac et de diéthylamine en utilisant une technique d'application de revêtement par fusion (HMC), comprenant les étapes de fusion, de mélange, d'application de revêtement, de stratification et de coupe.
PCT/IB2021/055856 2020-07-01 2021-06-30 Timbre transdermique de diclofénac et son procédé WO2022003585A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN202041027968 2020-07-01
IN202041027968 2020-07-01

Publications (1)

Publication Number Publication Date
WO2022003585A1 true WO2022003585A1 (fr) 2022-01-06

Family

ID=79315645

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2021/055856 WO2022003585A1 (fr) 2020-07-01 2021-06-30 Timbre transdermique de diclofénac et son procédé

Country Status (1)

Country Link
WO (1) WO2022003585A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2476622A1 (fr) * 2002-02-19 2003-08-28 Hisamitsu Pharmaceutical Co., Inc. Timbre transdermique
WO2014068600A1 (fr) * 2012-11-02 2014-05-08 Zydus Technologies Limited Système transdermique stable d'administration de médicaments comprenant du diclofénac

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2476622A1 (fr) * 2002-02-19 2003-08-28 Hisamitsu Pharmaceutical Co., Inc. Timbre transdermique
WO2014068600A1 (fr) * 2012-11-02 2014-05-08 Zydus Technologies Limited Système transdermique stable d'administration de médicaments comprenant du diclofénac

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
XU PENG-GANG, LEI XI-FENG, REN BAO-DI, LV SHUI-YING, ZHANG JUN-LI: "Diclofenac transdermal patch versus the sustained release tablet: A randomized clinical trial in rheumatoid arthritic patients", TROPICAL JOURNAL OF PHARMACEUTICAL RESEARCH, PHARMACOTHERAPY GROUP, NG, vol. 16, no. 2, NG , pages 477, XP055897468, ISSN: 1596-5996, DOI: 10.4314/tjpr.v16i2.29 *

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