Hydroxy propyl Methyl Cellulose

HPMC is a very important ingredient in the pharmaceutical field when used as a pharmaceutical excipient for the manufacture of hollow capsules.

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Hydroxy propyl Methyl Cellulose (HPMC)

HPMC is a very important ingredient in the pharmaceutical field when used as a pharmaceutical excipient for the manufacture of hollow capsules.

 

HPMC(Hydroxy propyl methylcellulose)

It is obtained by chemically modifying natural cellulose, specifically by grafting hydrophilic groups such as hydroxypropyl and methyl groups onto cellulose molecules through an etherification reaction. This modification gives cellulose better solubility and film-forming properties.

 

Product Parameters

Item 

Index

Density

 1.39g/cm³

Hydroxypropoxy (%)

6.0-10.0

Methoxy (%)

27-30

Loss on drying (%)

≤ 5

Ignition residue (%)

≤ 1.5

Heavy metals (ppm)

≤ 20

Arsenic salts (ppm)

≤ 2

Ethylene oxide

Not detected

2-chloroethanol

Not detected

Comply with the relevant standards of the 2020 edition (Volume 4) of the Chinese Pharmacopoeia.

Product Physicochemical characteristics

 

 

Appearance and properties: white or off-white fibrous or granular powder.

Solubility: almost insoluble in anhydrous ethanol, ether, and acetone; swells into a clear or slightly turbid colloidal solution in cold water.

Stability: The solid is flammable and incompatible with strong oxidants.

 

Dissolution Method

1. Stir and disperse with hot water first, then cool to room temperature or add some cold water and stir and cool to dissolve.

2. If agglomeration occurs during dissolution, it is because the hot water temperature is lower than 80°C during dispersion and the stirring is insufficient. At this time, the temperature should be raised and stirred quickly.

3. If bubbles are generated during dissolution, they can be left to stand for 2-12 hours (the specific time is determined by the solution consistency) or removed by vacuuming, pressurizing, etc.

 

Advantages of Hydroxypropyl Methylcellulose for Plant Capsules

Hydroxypropyl methylcellulose is a plant-based raw material. It is not an animal-based raw material. There is no need to worry about mad cow disease, infectious diseases, foot-and-mouth disease and other diseases that may be caused by animal-based raw materials.

It does not contain animal protein and fat, is not easy to breed microorganisms, and has safe and stable quality.

It does not react with the contents, has strong chemical safety and stability, and has no cross-linking reaction.

It has a low water content and is very suitable for health foods or traditional Chinese medicine products with strong hygroscopicity.

It dissolves quickly in gastric acid, is easily absorbed by the human body, and is easy to exert the efficacy of drugs and health foods.

It can cover up the bitter taste of drugs or contents, making it easy for consumers to swallow.

No preservatives.

No allergens.

No genetically modified substances.

No plasticizers.

HPMC capsule

 

Application

 

 

As a capsule shell material

It has a strong protective effect on moisture- and oxygen-sensitive drugs, high drug solubility, and will not cause problems and phenomena such as delayed disintegration during storage. It is suitable for filling hygroscopic and moisture-sensitive drugs and drugs that can cause cross-linking of gelatin molecules. HPMC capsules have a higher solubility, which can be up to 10% higher than other types of capsules, and the average dissolution time of HPMC capsules is significantly shortened.

Production Process

Hydroxypropyl methylcellulose (HPMC) is a special material for capsules. Its production process is mainly based on the chemical modification of natural cellulose. The following is a simplified process overview of HPMC production:

1.Raw material preparation: First, it is necessary to extract high-purity cellulose from plant sources (such as wood or cotton). Cellulose is the basic raw material of HPMC.

2.Alkalinization treatment: Cellulose is reacted with a strong base such as sodium hydroxide (NaOH) and alkalized under specific conditions to form alkali cellulose. This step is usually carried out at low temperature to open the hydrogen bonds between cellulose chains and make the subsequent etherification reaction easier.

3.Etherification reaction: On the basis of alkali cellulose, methyl chloride (for the introduction of methyl) and propylene oxide (for the introduction of hydroxypropyl) are added, and the etherification reaction is carried out under high temperature and high pressure conditions.

In this process, the hydroxyl group (-OH) on the cellulose molecule is partially replaced by methoxy (-OCH₃) and hydroxypropoxy (-OCH₂CHOHCH₃), thereby obtaining hydroxypropyl methylcellulose.

4.Neutralization and washing: After the etherification reaction is completed, the product needs to be neutralized with an acid solution to remove the residual alkali, and the by-products and unreacted starting materials need to be removed by multiple water washings.

5.Drying and crushing: The HPMC wet material after purification needs to be dried to remove moisture. The dried product may also need further crushing and screening to ensure that the particle size distribution meets the requirements.

6.Quality inspection: Finally, the finished product is strictly tested for quality, including viscosity, degree of substitution (the ratio of methoxy and hydroxypropoxy), purity and other indicators to ensure that the product meets the pharmaceutical standards.

 

Storage

Protect from sunlight, rain and moisture, and store in a sealed and dry place.

 

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