Low Substitution - Hydroxypropyl Cellulose

Low-substituted hydroxypropyl cellulose is a pharmaceutical auxiliary material specially made for tablet production. This product is made of alkali cellulose as raw material through propylene oxide etherification.

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Low substitution - HydroxyPropyl Cellulose(L-HPC)

Low-substituted hydroxypropyl cellulose is a pharmaceutical auxiliary material specially made for tablet production. This product is made of alkali cellulose as raw material through propylene oxide etherification.

 

 

L-HPC(Low substitution - HydroxyPropyl Cellulose)

L-HPC is a white powder, odorless and tasteless, insoluble in water and organic solvents (acetone, ethanol, ether, etc.), but can swell rapidly in water, with different swelling degrees depending on the hydroxypropoxy content.
L-HPC is a non-ionic compound, which is not affected by the pH value of gastric and intestinal fluids, nor does it react with common drugs.

 

 

Product Parameters

Item 

Index

Characteristics

White or off-white powder, odorless and tasteless

Identification

Complies with the Chinese Pharmacopoeia 2020 Edition (Volume 4)

Hydroxypropoxyl content

5.0%-16.0%

PH

5.0-7.5

Loss on drying

≤5.0%

Burning residue

≤ 1.0%

Chloride

≤ 0.20%

Iron salt

≤0.010%

Arsenic salts

≤ 0.0002%

Heavy metal

≤ 10 ppm

 

Product Physicochemical characteristics

 

The structure of L-HPC contains a large number of hydrophilic groups, huge internal surface and porosity, fast moisture absorption speed, strong swelling (much better than starch), which can accelerate the disintegration of tablets with poor disintegration and the fineness of dispersion after disintegration, thereby accelerating the dissolution rate of the drug. At the same time, its rough structure can have a greater mosaic effect with the drug, enhancing the bonding strength, thereby improving the hardness and smoothness of the tablet. It is the preferred disintegrant for tablets.

 

 

Application

This product is mainly used as a tablet disintegrant and filler to increase the disintegration rate of tablets. At the same time, this product has a bonding effect, which can also promote the formation of drugs that are difficult to form and increase the hardness of tablets. It can be used for diffuse granulation, added to dry granules, and added to starch slurry as a binder, all of which can achieve the effect of increasing tablet hardness and improving tablet disintegration.

  • 01
    Tablet - Disintegrants

    It can accelerate the disintegration of tablets with poor disintegration and the fineness of the dispersion after disintegration, thereby improving bioavailability.

  • 02
    Tablet - Adhesive

    It has a bonding effect and can also promote the forming of drugs that are difficult to form and increase the hardness of tablets.

 

Product Model

Model

LH-20

LH-21

LH-22

Hydroxypropoxy

13.0%-16.0%

10.0%-12.9%

7.0%-9.9%

Particle size

≥106μm particles cumulative weight ≤1%

≤75μm particles cumulative weight ≥90%

 

Specific Dosage

1. The dosage of this product is generally about 2-5%. It can be used for internal addition in wet granulation in tablet production, or external addition or internal and external addition at the same time for better results.

2. When used as a tablet adhesive, the general dosage of wet granulation is 2-20%.

 

Production Process

Low Substituted Hydroxypropyl Cellulose (L-HPC) is a chemically modified cellulose derivative with good disintegration and adhesion properties. It is widely used in the pharmaceutical industry as a disintegrant for tablets and capsules. The following is an overview of its basic production process:

1.Raw material preparation

First, high-quality cellulose raw materials, usually from wood pulp or cotton linter, need to be prepared. Cellulose needs to be refined to ensure purity and remove any impurities that may affect subsequent reactions.

2.Hydroxypropylation reaction

Alkalization step: The refined cellulose is mixed with sodium hydroxide (NaOH) and alkalized at a certain temperature. This step converts the cellulose into alkali cellulose, increasing its reactivity.

Etherification reaction: Propylene oxide is added to the alkalized cellulose and the etherification reaction is carried out under controlled conditions (such as specific temperature and pressure). During this process, the oxygen ring in the propylene oxide molecule opens and reacts with the hydroxyl group on the cellulose chain to form hydroxypropyl side chains.

3.Neutralization and washing

After the reaction is completed, the excess alkali needs to be neutralized with an acid (such as acetic acid) to adjust the pH to a neutral range.
The product is then washed with water several times to remove unreacted chemicals and other by-products.

4.Drying and crushing

The thoroughly washed L-HPC wet material needs to be dried to remove excess water. This can be done by spray drying, drum drying or other appropriate drying methods.
Finally, the dried material is crushed into the required particle size, and the particle size distribution is ensured to meet the standard requirements through screening and other processes.

5.Quality Control

Strict quality control measures are required throughout the production process, including the selection of raw materials, intermediate testing, and performance testing of the final product (such as substitution determination, solubility inspection, particle size analysis, etc.) to ensure stable and reliable product quality.

Tips:

The specific process parameters (such as temperature, time, material ratio, etc.) will vary according to different production processes. For example, one improved method is to use wood pulp as the starting material. By controlling the specific conditions of the alkalization, etherification, neutralization and other steps (such as the mass ratio of wood pulp, sodium hydroxide and water, the amount of propylene oxide, the reaction temperature and time, etc.), the production cost can be reduced and environmental pollution can be reduced.

Package

 

Cardboard barrel lined with polyethylene sealed bag.

Net weight: 25.0kg/barrel.

Pay attention to moisture-proof!

 

 

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