Plantago seed

Identification

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Name
Plantago seed
Accession Number
DB11097
Type
Biotech
Groups
Approved, Investigational
Description

Platango seeds refer to the seeds collected from various species of plantago trees. It is found in some laxatives for treating occasional constipation and restoring regularity in bowel movements. Its potential benefit in maintaining remission in ulcerative colitis has been studied 1.

Regardless, this agent is most predominantly used as a gentle laxative agent in many parts of the world that is more commonly referred as psyllium or psyllium husk.

Synonyms
  • Psyllium
  • Psyllium husk
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Bekunis Light GranulesTabletOralRoha Arzneimittel Gmbh1992-12-311999-03-04Canada
Best Choice Fiber LaxativeCapsule0.52 g/1OralBest Choice (Valu Merchandisers Company)2019-05-16Not applicableUs
Best Choice Fiber Therapy Orange FlavorPowder3.4 g/12gOralBest Choice (Valu Merchandisers Company)2019-05-15Not applicableUs
Best Choice Fiber Therapy original coarsePowder3.4 g/7gOralBest Choice (Valu Merchandisers Company)2019-05-14Not applicableUs
Bulk-forming LaxativePowder, for suspension3.4 g/7gOralHealth Mart2012-04-19Not applicableUs
CareoneCapsule0.52 g/1OralFoodhold Usa2019-04-16Not applicableUs
CAREONE Orange FlavoredPowder3.4 g/5.8gOralFoodhold Usa2019-04-18Not applicableUs
ClaraGranule3.25 g/5gOralHandock Cosmetics Inc2011-08-26Not applicableUs
ClaraGranule2.45 g/5gOralHandock Cosmetics Co., Ltd.2017-03-03Not applicableUs
ClaraGranule3.25 g/5gOralHandock Cosmetics Inc2011-11-112017-08-01Us
Additional Data Available
  • Application Number
    Application Number

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  • Product Code
    Product Code

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
ClaraPlantago seed (2.45 g/5g) + Garcinia gummi-gutta fruit (0.45 g/5g)GranuleOralHandock Cosmetics Co., Ltd.2017-03-03Not applicableUs
FloralaxPlantago seed (2.8 g) + Wheat (1 g)PowderOralFlora Manufacturing And Distributing Ltd.2002-08-292006-08-03Canada
Konsyl Overnight Relief Senna PromptPlantago seed (500 mg/1) + Sennosides (9 mg/1)CapsuleOralKonsyl Pharmaceuticals, Inc.2011-04-01Not applicableUs
Metamucil Therapy for RegularityPlantago seed (3.4 g/12g) + Plantago seed (3.4 g/12g)KitOralProcter And Gamble1989-03-312016-08-11Us
Metamucil Therapy for RegularityPlantago seed (3.4 g/12g) + Plantago seed (3.4 g/12g)KitOralProcter And Gamble1989-03-312016-08-11Us
Metamucil Therapy for RegularityPlantago seed (3.4 g/5.8g) + Plantago seed (3.4 g/5.8g)KitOralProcter And Gamble1994-12-152016-08-11Us
Metamucil Therapy for RegularityPlantago seed (3.4 g/5.8g) + Plantago seed (3.4 g/5.8g)KitOralProcter And Gamble1994-12-152016-08-11Us
Multilax 1 CapPlantago seed (378 mg) + Sennosides (92 mg)CapsuleOralNature's Way Of Canada Ltd.1984-12-312004-07-26Canada
Prodiem PlusPlantago seed (542 mg) + Sennosides (124 mg)PowderOralNovartis1996-07-302006-07-04Canada
Prodiem Plus PowderPlantago seed (542 mg) + Sennosides (124 mg)PowderOralRhone Poulenc Rorer1993-12-311997-08-13Canada
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
ClaraPlantago seed (2.45 g/5g) + Garcinia gummi-gutta fruit (0.45 g/5g)GranuleOralHandock Cosmetics Co., Ltd.2017-03-03Not applicableUs
ClaraPlantago seed (3.25 g/5g)GranuleOralHandock Cosmetics Inc2011-08-26Not applicableUs
ClaraPlantago seed (3.25 g/5g)GranuleOralHandock Cosmetics Inc2011-11-112017-08-01Us
Categories
UNII
9C60Y73166
CAS number
8063-16-9

Pharmacology

Indication

Indications include the treatment of patients needing a high fibre regime, perhaps for: (a) the relief of constipation, including constipation in pregnancy and the maintenance of regularity; (b) the management of bowel function in patients with colostomy, ileostomy, hemorrhoids, anal fissure, chronic diarrhea with diverticular disease, irritable bowel syndrome, and ulcerative colitis 3.

Pharmacodynamics

The active ingredient psyllium husk is comprised of the episperm and collapsed adjacent layers removed from the seeds of Plantago afar L. or Plantago indica L. 3. Psyllium husk is abundant in alimentary fibres and mucilages, with its mucilage content in particular being higher than that of other plantago species 3. Specifically, psyllium husk is capable of absorbing up to 40 times its own weight in water 3. Psyllium husk consists of 85% water-soluble fibre - it is subsequently partly fermentable (in vitro 72% unfermentable residue) and acts by hydration in the bowel 3.

Gastrointestinal tract motility and transit rate is capable of being modified by psyllium husk via mechanical stimulation of the gut wall as a result of the increase in intestinal bulk by water and the decrease in viscosity of the luminal contents 3. Taken with an adequate amount of liquid (at least 30 ml per 1 g of the agent), psyllium husk produces an increased volume of intestinal contents as a result of its highly bulking properties and therefore a stretch stimulus which triggers a defecation 3. Concurrently, the swollen mass of mucilage generates a lubricating layer that makes the transit of the intestinal contents easier 3.

Mechanism of action

Psyllium seeds are comprised of dietary fibre which, when mixed with water forms a gel-like mass that works as a mild laxative Label. This gel-like mass subsequently moves down a patient's digestive system and makes stools softer by increasing their water contents Label. At the same time psyllium seed lubricates the intestine, which improves the transit of stools Label. Moreover, as the presence of the gel-like mass increases the stool bulk it also increases the tension and/or the stretch stimulus in the bowel wall which serves to trigger bowel movements Label.

The dietary fibre of which psyllium husk is comprised is fermented to various degrees by bacteria in the colon, resulting in production of carbon dioxide, hydrogen, methane, water, and short chain fatty acids, which are absorbed and brought into the hepatic circulation 3. In humans, such fibre reaches the large bowel in a highly polymerized form that is fermented to a limited extent, resulting in increased fecal concentration and excretion of short chain fatty acids 3.

Additional Data Available
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Absorption

Psyllium husk is capable of hydration and swelling to form a mucilage because it is only partially solubilized 3. The polysaccharide dietary fibres of which psyllium husk is comprised of need to be hydrolyzed to monosaccharides before intestinal absorption can occur 3. The sugar residues of the xylan backbone and side chains are joined by beta-linkages however, which cannot be broken by human digestive enzymes 3.

Less than 10% of the mucilage gets hydrolyzed in the stomach, with formation of free arabinose 3. Intestinal absorption of the free arabinose is about 85% to 93% 3. As a consequence, psyllium remains predominantly in the gastrointestinal tract as a 'bulk' agent that passes largely unchanged throughout the gut 4. The agent has remarkable water holding capacity because of its high hemicellulose content 4.

Volume of distribution

Psyllium husk when administered as intended largely undergoes little absorption into the body and plasma.

Protein binding

The protein binding of psyllium husk is not formally documented at this time. Regardless, because psyllium husk is largely not adsorbed when administered, it is believed that the drug may not exhibit any kind of protein binding 2.

Metabolism

As psyllium remains largely in the gut as a 'bulk' agent that passes predominantly unchanged throughout the gastrointestinal tract, there is little opportunity for marked absorption into or metabolism by the body 4.

Route of elimination

Psyllium husk when administered as indicated is usually excreted in the faeces 2.

Half life

The half-life of psyllium husk is not formally documented at this time. Regardless, because psyllium husk is largely not adsorbed when administered, it is believed that the drug may not exhibit any kind of half-life 2.

Clearance

Psyllium husk when administered as intended largely undergoes little absorption into the body and plasma.

Toxicity

Overdose with psyllium husk can cause abdominal discomfort, flatulence, and/or intestinal obstruction 3.

The LD50 of psyllium husk administered orally to mice has been observed in some studies to occur in doses up to 2940 mg/kg or 3360 mg/kg in rats 5.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
AcetazolamideThe risk or severity of adverse effects can be increased when Acetazolamide is combined with Plantago seed.
AclidiniumThe therapeutic efficacy of Plantago seed can be decreased when used in combination with Aclidinium.
AgmatineThe therapeutic efficacy of Plantago seed can be decreased when used in combination with Agmatine.
AlcuroniumThe therapeutic efficacy of Plantago seed can be decreased when used in combination with Alcuronium.
AlfentanilThe therapeutic efficacy of Plantago seed can be decreased when used in combination with Alfentanil.
AlloinThe risk or severity of adverse effects can be increased when Plantago seed is combined with Alloin.
AlphacetylmethadolThe therapeutic efficacy of Plantago seed can be decreased when used in combination with Alphacetylmethadol.
AlphaprodineThe therapeutic efficacy of Plantago seed can be decreased when used in combination with Alphaprodine.
AmantadineThe therapeutic efficacy of Plantago seed can be decreased when used in combination with Amantadine.
AmilorideThe risk or severity of adverse effects can be increased when Amiloride is combined with Plantago seed.
Additional Data Available
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Food Interactions
Not Available

References

General References
  1. Fernandez-Banares F, Hinojosa J, Sanchez-Lombrana JL, Navarro E, Martinez-Salmeron JF, Garcia-Puges A, Gonzalez-Huix F, Riera J, Gonzalez-Lara V, Dominguez-Abascal F, Gine JJ, Moles J, Gomollon F, Gassull MA: Randomized clinical trial of Plantago ovata seeds (dietary fiber) as compared with mesalamine in maintaining remission in ulcerative colitis. Spanish Group for the Study of Crohn's Disease and Ulcerative Colitis (GETECCU). Am J Gastroenterol. 1999 Feb;94(2):427-33. [PubMed:10022641]
  2. Jennifer J. Yeager, Mary Beth Winton, Linda E. McCuistion, Kathleen DiMaggio (2018). Pharmacology: A Patient-Centered Nursing Process Approach. Elsevier Health Sciences. [ISBN:9780323399166]
  3. Electronic Medicines Compendium: Fybogel Orange Monograph [Link]
  4. Sigma Aldrich: Psyllium Profile [Link]
  5. European Medicines Agency: Community Herbal Monograph on Plantago afar L. et. Plantago indica L., semen [Link]
External Links
PubChem Substance
347911115
AHFS Codes
  • 56:12.00 — Cathartics and Laxatives
  • 92:01.00* — Herbs and Natural Products
FDA label
Download (85.2 KB)
MSDS
Download (47.2 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
2TerminatedSupportive CareConstipation-predominant Irritable Bowel Syndrome (IBS-C)1
2, 3CompletedTreatmentFecal Incontinence1
4CompletedPreventionConstipation / Incontinence1
4CompletedTreatmentGastro-esophageal Reflux Disease (GERD)1
4CompletedTreatmentHigh Cholesterol1
4RecruitingTreatmentType2 Diabetes Mellitus1
Not AvailableCompletedOtherConstipation1
Not AvailableCompletedPreventionFunctional Disorder of Intestine1
Not AvailableCompletedTreatmentColonic Diseases, Functional1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
TabletOral
GranuleOral
GranuleOral2.45 g/5g
GranuleOral3.25 g/5g
PowderOral6 g/6.0g
PowderOral3.4 g/7.2g
PowderOral3.4 g/5.89g
Granule, for solutionOral3.4 g/7g
Granule, for solutionOral3.4 g/12g
Granule, for solutionOral3.5 g/5.8g
CapsuleOral0.52 g/1
CapsuleOral520 mg/1
Powder, for suspensionOral3.4 g/7g
Granule, for solutionOral3.4 g/5.4g
CapsuleOral
PowderOral
LiquidOral
Powder, for solutionOral3.4 g/7g
CapsuleOral.52 g/1
GranuleOral2.75 g/5g
Powder, for suspensionOral3.4 g/5.8g
PowderOral1 g/1g
CapsuleOral20 mg/1
PowderOral6 g/6g
GranuleOral4.3 g/6g
GranuleOral3.4 g/6.5g
GranuleOral6 g/9g
PowderTopical60 mg/1g
GranuleOral3.4 g/11g
GranuleOral3.4 g/12g
GranuleOral6 g/6g
CapsuleOral
GranuleOral3.5 g/5.8g
PowderTopical3.5 g/5.8g
PowderOral3.4 g/5.78g
Powder, for solutionOral
KitOral
PowderOral3.3 g/5.95g
PowderOral3.4 g/12g
PowderOral3400 mg/1g
GranuleOral3.4 g/100g
PowderOral3.4 g/11g
PowderOral3.4 g/5.8g
PowderOral3.4 g/7g
PowderOral3.4 g/5.4g
PowderOral15 g/99g
Powder, for solutionOral3.4 g/100g
PowderOral3.4 g/5.79g
Powder, for suspensionOral3.4 g/11g
PowderOral
Powder, for solutionOral3.4 g/5.8g
Not applicableOral
Powder, for solutionOral3.4 g/5g
Powder, for solutionOral3.4 g/12g
Granule, for solutionOral3.4 g/100g
Powder, for solutionOral0.486 g/1g
Powder, for solutionOral0.604 g/1g
Powder, for suspensionOral3.4 g/12g
Powder, for solutionOral
Prices
Not Available
Patents
Not Available

Properties

State
Not Available
Experimental Properties
Not Available

Taxonomy

Classification
Not classified

Drug created on December 03, 2015 09:51 / Updated on November 20, 2019 12:32