Crospovidone
Crospovidone is a synthetic PVP (polyvinyl pyrrolidone) and insoluble in water and tablet disintegrant. Crospovidone is one of the ingredients in Arvin Kala’s diverse product portfolio.
Description
Crospovidone is a white to creamy-white, finely divided, free-flowing, practically tasteless, and odorless or nearly odorless hygroscopic powder.
Applications in Pharmaceutical Formulation or Technology
Crospovidone is a water-insoluble tablet disintegrant and dissolution agent used at concentrations of 2 to 5% in tablets prepared by direct compression or wet and dry granulation methods. It quickly demonstrates high capillary activity and significant hydration capacity, with minimal gel formation. Studies indicate that the particle size of crospovidone significantly affects the disintegration of analgesic tablets, with larger particles providing faster disintegration than smaller ones. Crospovidone can also enhance the solubility of poorly soluble drugs through the co-evaporation technique, where the drug is adsorbed onto crospovidone in the presence of a suitable solvent, which is then evaporated, resulting in a faster dissolution rate.
Stability and Storage Conditions
Since crospovidone is hygroscopic, it should be stored in an airtight container in a cool, dry place.
Method of Manufacture
Acetylene and formaldehyde react in the presence of a highly active catalyst to form butynediol, which is then hydrogenated to butanediol and cyclodehydrogenated to produce butyrolactone. Pyrrolidone is created by reacting butyrolactone with ammonia. This is followed by a vinylation reaction where pyrrolidone and acetylene are reacted under pressure. The monomer vinylpyrrolidone is then polymerized in solution using a catalyst. Crospovidone is prepared through a ‘popcorn polymerization’ process.
Safety
Crospovidone is used in oral pharmaceutical formulations and is generally considered nontoxic and nonirritant. Short-term animal toxicity studies have shown no adverse effects associated with crospovidone. However, due to the lack of available data, the WHO has not specified an acceptable daily intake for humans.
LD50 (mouse, IP): 12 g/kg
Handling Precautions
Follow standard precautions based on the circumstances and amount of material being handled. It is recommended to use eye protection, gloves, and a dust mask.
Chemical-physical values
| TEST ITEM | Unit | Specification |
|---|---|---|
|
Appearance |
|
White or yellowish- white hygroscopic powder or flakes |
|
Identification D |
|
Residue fracti on>LS%o as type A,
s15% as type B |
|
Solubility (Insoluble in) |
|
practically insoluble in water, in ethanol 96 percent and inmethylene chloride |
|
Loss on drying |
% |
Max 5.0 |
|
Water |
% |
Max 5.0 |
|
PH |
in 1% suspension |
Min 5.0 &
Max 8.0
|
|
Acid-Alcohol soluble matter |
% |
Max 1.0 |
|
Water-soluble matter |
|
Max 1.0 |
|
Free N-vinylpyrrolidone |
ppm |
Max 10 |
| TEST ITEM | Unit | Specification |
|---|---|---|
|
Assay, as Nitrogen content |
% |
Min 11 &
Max 12.8
|
|
Residue on ignition |
% |
Max 0.1 |
|
Peroxide |
ppm |
Max 400 |
|
Hydration Capacity |
|
Min 3.0 &
Max 9.0
|
|
Heavy metals |
ppm |
Max 10 |
|
Average particle size (D50) |
µm |
Min 70 &
Max 110
|
|
Total Aerobic Microbial Count |
Cfu/g |
Max 100 |
|
Total combined Yeasts and Molds Count |
Cfu/g |
Max 100 |
|
Staphylococcus aureus |
In 1g |
Negative |
|
Salmonella |
In 10g |
Negative |
|
Pseudomonas aeruginosa |
In 1g |
Negative |
|
E. coli |
In 1g |
Negative |
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