MedPath

Gelatin

Generic Name
Gelatin
Drug Type
Small Molecule
CAS Number
9000-70-8
Unique Ingredient Identifier
2G86QN327L

Overview

Gelatin is a multifunctional ingredient that is used in foods, pharmaceuticals, cosmetics, and photographic films as a gelling agent, stabilizer, thickener, emulsifier, as well as film former. As a thermoreversible hydrocolloid with a small gap between its melting and gelling temperatures, gelatin provides unique advantages over carbohydrate-based gelling agents. Gelatin is mainly produced from porcine skin, and cattle hides and bones. Some alternative raw substances have recently garnered attention from both researchers and the industry not only because they overcome religious concerns shared by both Jews and Muslims but also because they may provide scientific advantages over gelatins from mammal origins. Fish skins from a number of fish species a type of substance that has been comprehensively studied as a source for gelatin production. Fish skins have a significant potential for the production of high-quality gelatin with different melting and gelling temperatures over a much larger range than mammalian gelatins but have a sufficiently high level of gel strength and viscosity. Interestingly, horse gelatin has been studied and it was found that in the horse, gelatin influences the homeostasis of the amino acids required for cartilage synthesis . An increasing number of novel applications have been found for collagen and gelatin. Gelatin is generally recognized as safe (GRAS) by the FDA to be a non-hazardous food or food ingredient. The FDA withdrew its approval for the use of all intravenous drug products containing gelatin. Gelatin continues to be approved for other routes of administration.

Background

Gelatin is a multifunctional ingredient that is used in foods, pharmaceuticals, cosmetics, and photographic films as a gelling agent, stabilizer, thickener, emulsifier, as well as film former. As a thermoreversible hydrocolloid with a small gap between its melting and gelling temperatures, gelatin provides unique advantages over carbohydrate-based gelling agents. Gelatin is mainly produced from porcine skin, and cattle hides and bones. Some alternative raw substances have recently garnered attention from both researchers and the industry not only because they overcome religious concerns shared by both Jews and Muslims but also because they may provide scientific advantages over gelatins from mammal origins. Fish skins from a number of fish species a type of substance that has been comprehensively studied as a source for gelatin production. Fish skins have a significant potential for the production of high-quality gelatin with different melting and gelling temperatures over a much larger range than mammalian gelatins but have a sufficiently high level of gel strength and viscosity. Interestingly, horse gelatin has been studied and it was found that in the horse, gelatin influences the homeostasis of the amino acids required for cartilage synthesis . An increasing number of novel applications have been found for collagen and gelatin. Gelatin is generally recognized as safe (GRAS) by the FDA to be a non-hazardous food or food ingredient. The FDA withdrew its approval for the use of all intravenous drug products containing gelatin. Gelatin continues to be approved for other routes of administration.

Indication

Gelatin is used for weight loss and for treating osteoarthritis, rheumatoid arthritis, and brittle bones (osteoporosis). Some people also use it for strengthening bones, joints, and fingernails. Gelatin is also used for improving hair condition and to shorten the recovery after exercise and sports-related injury . Gelatin is used in preparations of foods, cosmetics, and medicine . Plasma volume expander in hypovolaemic shock . Haemostatic . Gelatin-based hydrogels are being used in drug delivery and tissue engineering because they are able to promote cell adhesion and proliferation. In addition, these hydrogels can be used as wound dressings because of their attractive fluid absorbance properties. Manufacturing technologies such as ultraviolet stereolithography and two-photon polymerization can be used to prepare structures containing photosensitive gelatin-based hydrogels .

Associated Conditions

  • Hypovolaemia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/05/30
Not Applicable
Active, not recruiting
Recep Tayyip Erdogan University
2023/12/19
Phase 1
Completed
2023/08/02
Not Applicable
Completed
Fifth Affiliated Hospital of Guangzhou Medical University
2020/05/27
Not Applicable
Completed
2018/01/18
Phase 4
UNKNOWN
Karim ehab gerges
2017/06/21
Phase 2
Completed
Alborz Medical University
2016/03/22
Phase 4
Terminated
2014/10/31
Phase 1
Completed
Medical University of Warsaw
2014/05/15
Early Phase 1
Completed
2014/01/20
Phase 1
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AnazaoHealth Corporation
51808-220
INTRAVENOUS
4.5 mg in 1 1
12/2/2012

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Luna 1
443659
All Natural Pharmacy Pty Ltd
Medicine
A
3/13/2024
METAGENICS ARTHREX
199296
Medicine
A
7/11/2012
HSN Collagen Plus
388477
Medicine
A
5/16/2022
Inner Beauty Collagen 6-in-1
299910
Medicine
A
2/22/2018
Collagen Peptides Bone Booster
324701
Medicine
A
10/11/2019
Swisse Ultiboost Radiant Skin
291808
Medicine
A
7/21/2017
Collagen Peptides Bone Booster Lemon Lime
402095
Medicine
A
1/11/2023
Australian Squalene
325696
Medicine
A
10/29/2019
Australian Shark Liver Oil - Alkoxyglycerol
325708
Medicine
A
10/29/2019
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