What is the role of fumaric acid in tablets?

December 18, 2025

What is the role of fumaric acid in tablets?

The job of fumaric acid in tablets is to make them better and work well. Makers use this compound for a few big reasons:

  1. It makes stable salts. These salts protect the main ingredients from breaking down.
  2. It keeps the pH level right inside the tablet. This helps protect sensitive parts from getting hurt.
  3. It stops the tablet from soaking up too much water. This keeps the tablet strong and working as it should.
    NORBIDAR Fumaric Acid is a top pick in the field because it is very pure and reliable. Fumaric Acid For Pharma products and Fumaric Acid Foods get these good things too. This makes fumaric acid useful for many different uses.

Key Takeaways

  • Fumaric acid helps keep tablets stable by keeping the pH right. This protects the main ingredients from breaking down. This compound helps the body absorb medicine better. It lets medicine dissolve faster and get into the blood quickly. Fumaric acid also works as a lubricant when making tablets. It stops tablets from sticking and helps make them better. Using very pure fumaric acid, like NORBIDAR, keeps medicines safe and working well. Fumaric acid helps treat problems like psoriasis and multiple sclerosis. This makes it an important part of many medicines.

Fumaric acid properties

Fumaric acid properties

Chemical characteristics

Fumaric acid looks like a white, crystal-like powder. It is very pure, usually at least 99.5% in medicines. It melts at about 287°C, so it can handle high heat. This helps it stay stable when making tablets. Its molecular weight is 116.07 g/mol. It has two acidic groups, with pKa values of 3.02 and 4.44. These things help it make a steady place for active ingredients to dissolve.

Fumaric acid does not dissolve much in water. Only about 6.6 grams dissolve in 100 mL at 25°C. This helps keep the pH inside the tablet steady. A steady pH helps weakly basic drugs dissolve better. This is important for chemical stability. It also helps the drug dissolve at the right speed. Fumaric acid is about 1.5 times more acidic than citric acid. This strong acidity helps control how fast the drug dissolves.

Note: The melting point and thermal stability of fumaric acid change how it acts when making tablets. These things affect how fast it dissolves and help keep it stable in the final product.

Here is a table that shows its main chemical properties:

PropertyValue
Purity≥99.5%
Melting point286–302°C
Molecular weight116.07 g/mol
pKa13.02
pKa24.44
Solubility in water6.6 g/100 mL at 25°C
Thermal stabilityHigh
AcidityStrong
AppearanceWhite crystalline powder

Safety profile

Fumaric acid is used a lot in tablets and controlled-release medicines. It is also found in some drugs for autoimmune diseases. Most people do not have problems with it. But some studies found serious side effects. These include stomach problems like ulcers and bleeding. Rarely, it can cause holes or blockages in the stomach or intestines. Some people needed to go to the hospital or have surgery. A few people died from these problems.

Makers use fumaric acid because it keeps tablets stable and helps them dissolve slowly. But they must watch for stomach problems in patients. The good things about chemical stability and steady dissolving make it useful. Still, safety is always the most important thing in medicine.

Fumaric acid for pharma applications

NORBIDAR Fumaric Acid is a top choice for medicine. It is very pure and stable. This makes it great for many tablet types. Fumaric acid in pharma helps in many ways. It makes drugs more stable and helps make tablets. This part will show how fumaric acid helps control pH, acts as an excipient and lubricant, and treats some diseases.

pH adjustment and stabilization

Fumaric acid for pharma keeps the pH level steady in tablets. Many drugs need the right pH to work well. Fumaric acid makes the tablet more acidic. This helps weakly basic drugs dissolve better. The drug can then release at the right speed and reach the body.

  • Fumaric acid for pharma changes the pH. It helps weakly basic drugs dissolve the same way each time.
  • Adding fumaric acid to tablets changes the pH inside. This helps the drug come out better and makes the medicine work well.
  • Scientists have checked how fumaric acid helps drugs that do not dissolve easily.

Tip: A steady pH in the tablet keeps the medicine safe and stable while it is stored.

The table below shows how fumaric acid for pharma helps in different ways:

Application TypeDescription
ExcipientsFumaric acid is used as an excipient in tablet formulations.
Drug FormulationsIt is in many drug formulas for therapy.
Treatment of ConditionsUsed for iron-deficiency anemia, heart problems, allergies, and autoimmune diseases.
Delivery MethodFumarates are put in enteric coated tablets for release in the intestine.

Excipient and lubricant roles

Fumaric acid for pharma is also an excipient and lubricant. As an excipient, it helps hold the tablet together. It also helps the drug come out of the tablet. As a lubricant, it stops the tablet from sticking to machines.

  • Fumaric acid for pharma keeps tablets from sticking. It makes them smooth and easy to handle.
  • In making tablets, fumaric acid helps powders flow and lowers friction.
  • Sodium stearyl fumarate, made from fumaric acid, is a common tablet lubricant.

The table below shows what fumaric acid does as an excipient and lubricant:

PropertyDescription
Chemical FormulaC22H39NaO4
Chemical Name2-Butenedioic acidiconoctadecyl ester, sodium salt
FunctionWorks as a lubricant and anti-adherent in tablets
ManufacturingMade by mixing stearic acid, fumaric acid, and sodium hydroxide

Therapeutic uses and impact on bioavailability

Fumaric acid for pharma is not just for making tablets. It is also used to treat diseases. Doctors use it for psoriasis and multiple sclerosis. In these cases, fumaric acid helps the body use the medicine better.

ConditionTherapeutic Use
Multiple Sclerosis (MS)Used as a first-line agent for relapsing remitting MS since 2014.
PsoriasisWorks well for people with moderate to severe psoriasis.

Fumaric acid for pharma helps make an acidic layer in coated tablets. This helps the drug dissolve and controls how it comes out in the body. Its strong acidity keeps the pH low for longer. This helps the drug dissolve at a steady rate.

Note: NORBIDAR Fumaric Acid is very pure and safe. It is trusted for medical use. Some other sources may not be as good.

Benefits of fumaric acid in tablets

Improved stability

Fumaric acid helps tablets stay strong and last longer. It keeps the pH at the right level. This protects the main ingredients from breaking down. When the pH is low, the tablet stays good for more time. Fumaric acid does not pull in much water. This keeps the tablet dry and stops it from getting sticky. The acid helps stop water from causing problems. This makes the tablet more stable.

The table below shows how fumaric acid affects stability and shelf life in tablet formulation:

Evidence DescriptionImpact on Stability and Shelf Life
Fumaric acid reacts with solventsCan cause degradation affecting drug stability
Formation of esters with methanolAlters chromatographic analysis results
Degradation during sample prepRequires careful selection of diluents to minimize impact

Fumaric acid also acts like an antioxidant. This helps protect the tablet from air and light. The tablet lasts longer and works as it should. Scientists found that fumaric acid keeps the tablet stable. It lowers the chance of the drug breaking down while stored.

Tip: Picking the right diluent when making samples helps keep the tablet stable.

Enhanced drug absorption

Fumaric acid helps the body take in medicine better. It makes the tablet dissolve faster in the stomach. This lets the medicine get into the blood more quickly. When the tablet dissolves fast, the medicine starts working sooner.

Studies show that one dose of a tablet with fumaric acid makes the medicine rise fast in the blood. Some drugs, like dipyridamole, get absorbed better when more fumaric acid is in the tablet. The table below explains these findings:

FindingDescription
Serum ConcentrationsA single oral dose leads to a quick rise in blood levels of the medicine.
Absorption ImprovementMore fumaric acid in granules means higher plasma concentrations.
Plasma ConcentrationThe amount of fumaric acid affects how much drug enters the bloodstream.

Fumaric acid helps drugs that do not dissolve well on their own. It helps the tablet break apart and release the medicine at the right speed. Some drugs, like loxoprofen sodium, move through the skin faster with fumaric acid. Other drugs, like PEC, dissolve better and work better with fumaric acid. The tablet stays stable, so the medicine works every time.

  • Fumaric acid helps some drugs move into the body faster.
  • It makes the medicine start working sooner.
  • It helps some medicines dissolve and work better.

Note: Eating food with the tablet can change how much medicine gets into the body. The amount absorbed may go down and become less steady.

Medications and products with fumaric acid

Medications and products with fumaric acid

Common pharma examples

Many medicines use fumaric acid to help them work. This ingredient is found in both active and inactive parts of different treatments. Some well-known medicines treat skin problems, nerve issues, allergies, and are also used in supplements. The table below lists some common examples:

Medication NameActive IngredientIndication
Skilarence®Dimethyl fumarate (DMF)Moderate-to-severe plaque psoriasis
TecfideraDimethyl fumarateMultiple sclerosis
Psorizide® ForteFumaric Acid (Fumaricum Acidum 1X)Dyshidrotic hand/foot eczema

NORBIDAR Fumaric Acid is also used in many other medicines. These include iron pills, antidotes, heart drugs, and allergy medicines. Here are more examples:

Product NameUse/Indication
Ferrous fumarateIron supplement for anemia
Sodium dimercaptosuccinateAntidote for heavy metal poisoning
Bisoprolol fumarateCardiovascular therapy
Ketotifen fumarateAsthma and allergic rhinitis
Chlorpheniramine maleate fumarateAllergy relief
Vonoprazan fumarateReflux esophagitis
Dimethyl fumarateAutoimmune disease therapy

Note: These products show that fumaric acid is used in many types of medicine today.

Why manufacturers choose fumaric acid

Manufacturers pick fumaric acid for a few big reasons. First, it is very pure and meets strict rules. Most medicine needs at least 99% purity to be safe and stable. This high quality helps keep patients safe and makes sure the medicine works well.

  • Meets purity standards of 99% or more
  • Has very little chloride, sulfate, or iron
  • Passes tests for leftover solvents and water

Fumaric acid is useful in many ways. It is an active ingredient in some treatments for psoriasis and multiple sclerosis. It is also an excipient, which helps keep tablets stable and lets them hold more medicine. As a lubricant, it can lower costs and help make tablets faster.

The table below shows some benefits:

Property/AdvantageDescription
Lubricant roleLess is needed to make tablets
Cost-effectivenessHelps lower costs in some medicines
Use in effervescent tabletsAdds value to special tablet types

Manufacturers like fumaric acid because it helps make safe, stable, and strong medicines for many health problems.

Fumaric acid helps make tablets strong and work well. Makers use it to keep medicine safe. It also helps medicine work better for people. Studies show fumaric acid starts antioxidant pathways. It lowers inflammation in the body.

  • It keeps cells safe from harm.
  • It helps the body take in medicine.
  • More people want fumaric acid in medicine now.
AspectDetail
Stability BenefitsFumaric acid makes tablets last longer and helps deliver medicine to the right place.
Clinical ImpactTests show it works for diseases like multiple sclerosis.

Picking pure fumaric acid like NORBIDAR helps medicine stand out. It also makes sure people get good results.

FAQ

What is fumaric acid used for in tablets?

Fumaric acid helps tablets last longer and stay strong. It keeps the pH at the right level inside the tablet. This helps the medicine work well and keeps it safe.

Is fumaric acid safe in medicines?

Most people can use medicines with fumaric acid without problems. Doctors and scientists check it to make sure it is safe. Some people might get stomach issues, so doctors watch for side effects.

How does fumaric acid improve drug absorption?

Fumaric acid helps the tablet break down faster in the stomach. This lets the medicine get into the blood more quickly. The body can use the medicine sooner and better.

Why do manufacturers choose NORBIDAR Fumaric Acid?

Manufacturers pick NORBIDAR Fumaric Acid because it is very pure and reliable. It meets strict rules for quality. This helps keep tablets stable and makes sure they work well.

Which medicines contain fumaric acid?

Many medicines have fumaric acid in them. Some treat psoriasis, multiple sclerosis, and iron deficiency. Others help with allergies or heart problems.

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