Overview
Alginic acid, also referred to as algin or alginate, is a hydrophilic or anionic polysaccharide isolated from certain brown seaweed (Phacophycae) via alkaline extraction. It is present in cell walls of brown algae where it forms a viscous gel when binding with water. Alginic acid is a linear polymer consisted of L-glucuronic acid and D-mannuronic acid residues connected via 1,4-glycosidic linkages . Available in different types of salt, alginic acid has been used in a variety of uses in food, cosmetics and pharmaceu-tical products for over 100 years . Alginic acid is an FDA-approved food ingredient in soup and soup mixes as an emulsifier, thickener, and stabilizer . It is also available in oral dietary supplements and is found in antacids such as Gaviscon to inhibit gastroesophageal reflux by creating a physical barrier in presence of gastric acid . Alginate-based raft-forming formulations in the management of heartburn and gastric acid reflux have been used worldwide for over 30 years .
Background
Alginic acid, also referred to as algin or alginate, is a hydrophilic or anionic polysaccharide isolated from certain brown seaweed (Phacophycae) via alkaline extraction. It is present in cell walls of brown algae where it forms a viscous gel when binding with water. Alginic acid is a linear polymer consisted of L-glucuronic acid and D-mannuronic acid residues connected via 1,4-glycosidic linkages . Available in different types of salt, alginic acid has been used in a variety of uses in food, cosmetics and pharmaceu-tical products for over 100 years . Alginic acid is an FDA-approved food ingredient in soup and soup mixes as an emulsifier, thickener, and stabilizer . It is also available in oral dietary supplements and is found in antacids such as Gaviscon to inhibit gastroesophageal reflux by creating a physical barrier in presence of gastric acid . Alginate-based raft-forming formulations in the management of heartburn and gastric acid reflux have been used worldwide for over 30 years .
Indication
Indicated for the management of gastric reflux, reflux oesophagitis, hiatus hernia, heartburn (including heartburn of pregnancy) and similar gastric distress .
Associated Conditions
- Dyspepsia
- Flatulence
- Gastro-esophageal Reflux Disease (GERD)
- Gastroesophageal Reflux
- Heartburn
- Reflux Acid
- Reflux Esophagitis (RE)
- Regurgitation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/11/29 | Phase 4 | Active, not recruiting | |||
2019/10/22 | Phase 4 | Completed | |||
2018/08/17 | Phase 4 | Completed | |||
2015/05/27 | Phase 2 | Completed | |||
2014/10/29 | Phase 4 | UNKNOWN | Chang Gung Memorial Hospital | ||
2014/06/06 | Phase 2 | Completed | |||
2013/06/17 | Phase 3 | Completed | |||
2013/06/05 | Phase 3 | Completed | |||
2011/10/12 | Phase 3 | Completed | TTY Biopharm | ||
2011/04/19 | Phase 3 | Completed | Chang Gung Memorial Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| GAVISCON PEPPERMINT TABLETS | SIN13947P | TABLET, CHEWABLE | 250MG | 4/14/2011 | |
| GASCOVID LIQUID | SIN16041P | SUSPENSION | 500 mg/10ml | 11/17/2020 | |
| GAVISCON ADVANCE-PEPPERMINT FLAVOUR SUSPENSION | SIN12635P | SUSPENSION | 1000 mg/10 ml | 12/24/2004 | |
| GAVISCON LIQUID SACHETS | SIN13738P | SUSPENSION | 500MG/10ML | 11/23/2009 | |
| GAVISCON DOUBLE ACTION LIQUID, SUSPENSION | SIN14016P | SUSPENSION | 500MG/10ML | 9/19/2011 | |
| GASCOVID ADVANCE LIQUID | SIN16042P | SUSPENSION | 1000 MG/10ML | 11/17/2020 | |
| GAVISCON LIQUID | SIN09494P | SUSPENSION | 500 mg/10 ml | 9/13/1997 | |
| GAVISCON DOUBLE ACTION TABLETS | SIN14194P | TABLET, CHEWABLE | 250MG | 7/17/2012 |
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 |
|---|---|---|---|---|---|
| GAVISCON EXTRA STRENGTH peppermint flavour chewable tablet blister pack | 156040 | Medicine | A | 10/21/2008 | |
| GAVISCON DUAL ACTION mixed berry flavour oral liquid bottle | 328032 | Medicine | A | 12/23/2019 | |
| GAVISCON INFANT oral powder sachet | 56093 | Medicine | A | 6/24/1996 | |
| MYLANTA 2GO ANTACID DUAL ACTION tablet blister pack | 14378 | Medicine | A | 9/20/1991 | |
| GAVISCON DUAL ACTION mixed berry chewable tablet blister pack | 327045 | Medicine | A | 12/3/2019 | |
| GAVISCON COOL cool mint flavour oral liquid bottle | 127289 | Medicine | A | 4/26/2006 | |
| GAVISCON EXTRA STRENGTH peppermint flavour chewable tablet bottle | 456108 | Medicine | A | 7/23/2024 | |
| GAVISCON EXTRA STRENGTH aniseed oral liquid bottle | 77810 | Medicine | A | 3/13/2001 | |
| GAVISCON aniseed flavour oral liquid bottle | 15383 | Medicine | A | 9/30/1991 | |
| Copy of GAVISCON DUAL ACTION peppermint flavour oral liquid bottle | 158117 | Medicine | A | 12/19/2008 |