Precise Fabrication of Ocular Inserts Using an Innovative Laser-Driven CaliCut Technology: In Vitro and In Vivo Evaluation.

CaliCut HME castor oil laser ocular inserts polymer precision

Journal

Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R

Informations de publication

Date de publication:
18 Dec 2023
Historique:
received: 13 08 2023
revised: 14 12 2023
accepted: 14 12 2023
medline: 21 12 2023
pubmed: 21 12 2023
entrez: 20 12 2023
Statut: aheadofprint

Résumé

Ocular inserts offer distinct advantages, including a preservative-free drug delivery system, the ability to provide tailored drug release, and ease of administration. The present research paper delves into the development of an innovative ocular insert using CaliCut technology. Complementing the hot melt extrusion (HME) process, CaliCut, an advanced technology in ocular insert development, employs precision laser gauging to achieve impeccable cutting of inserts with desired dimensions. Its intelligent control over the stretching process through auto feedback-based belt speed adjustment ensures unparalleled accuracy and consistency in dosage form manufacturing. Dry eye disease (DED) poses a significant challenge to ocular health, necessitating innovative approaches to alleviate its symptoms. In this pursuit, castor oil has emerged as a promising therapeutic agent, offering beneficial effects by increasing the thickness of the lipid layer in the tear film, thus improving tear film stability, and reducing tear evaporation. To harness these advantages, this study focuses on the development and comprehensive characterization of castor oil-based ocular inserts. Additionally, in-vivo irritancy evaluation in rabbits has been undertaken to assess the inserts' safety and biocompatibility. By harnessing the HME and CaliCut techniques in the formulation process, the study demonstrates their instrumental role in facilitating the successful development of ocular inserts.

Identifiants

pubmed: 38123067
pii: S0022-3549(23)00540-3
doi: 10.1016/j.xphs.2023.12.015
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Dhwani Rana (D)

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research -Ahmedabad (NIPER-A), India.

Jayesh Beladiya (J)

Department of Pharmacology, L.M. College of Pharmacy, Ahmedabad, India.

Devang Sheth (D)

Department of Pharmacology, L.M. College of Pharmacy, Ahmedabad, India.

Sagar Salave (S)

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research -Ahmedabad (NIPER-A), India.

Amit Sharma (A)

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research -Ahmedabad (NIPER-A), India.

Anil B Jindal (AB)

Department of Pharmacy, Birla Institute of Technology and Science Pilani (BITS PILANI), Pilani Campus, Rajasthan, 333031, India.

Rikin Patel (R)

Graduate School of Pharmacy, Gujarat Technological University Gandhinagar Campus. Gandhinagar, 382028, India.

Derajram Benival (D)

Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research -Ahmedabad (NIPER-A), India. Electronic address: derajram@niperahm.res.in.

Classifications MeSH