Crospovidone EC Granules are a specialized pharmaceutical excipient granule format based on cross-linked polyvinylpyrrolidone, also known as cross-linked PVP, polyvinylpolypyrrolidone (PVPP), and crospovidone. Crospovidone has CAS Number 9003-39-8 and the polymeric formula (C₆H₉NO)ₙ. The current USP-NF monograph identifies Crospovidone as a water-insoluble synthetic cross-linked homopolymer of N-vinyl-2-pyrrolidone and specifies a nitrogen content of 11.0%–12.8% calculated on the dried basis. USP also recognizes Type A and Type B according to particle size.
Crospovidone EC Granules refer to a granulated pharmaceutical excipient system in which the underlying crospovidone-based material is incorporated into an enteric-coated or enteric-protected granule format, where applicable to the finished product specification.
It is important to distinguish the underlying excipient from the finished EC granule system. Crospovidone itself is not an enteric coating polymer. Its established pharmaceutical function is primarily as a superdisintegrant, while enteric protection requires an appropriate pH-dependent coating system selected and controlled as part of the finished formulation.
Therefore, the EC designation should be used for the finished product only when the actual product specification defines an enteric-coated or enteric-protected granule system.
Cross-linked polyvinylpyrrolidone is a synthetic cross-linked polymer used as a pharmaceutical excipient. Unlike soluble povidone, crospovidone is water-insoluble. Its cross-linked structure provides water uptake and swelling characteristics that make it useful in oral solid formulation development.
The USP-NF monograph identifies Crospovidone as 1-ethenyl-2-pyrrolidinone homopolymer and 1-vinyl-2-pyrrolidinone homopolymer, CAS 9003-39-8. The current USP-NF definition specifies nitrogen at 11.0%–12.8% on the dried basis.
An enteric-coated granule system is designed to provide protection against the conditions encountered before reaching the intended intestinal environment. Enteric coating technology generally uses a pH-dependent polymeric coating system to control release according to the target formulation design.
For granules, coating coverage is particularly important because individual particles have a large total surface area. The finished granule system therefore requires appropriate coating development, process control and quality evaluation.
The exact coating polymer, coating level, particle-size distribution, coating thickness and dissolution profile should be specified according to the actual product specification rather than applying generic values.
Crospovidone is widely used as a pharmaceutical superdisintegrant. Its water-insoluble cross-linked structure allows it to interact with liquid without dissolving in the same manner as soluble polymers.
In a finished multiparticulate or granule formulation, crospovidone may contribute to formulation breakup and dispersion after the relevant coating or protective layer has performed its intended function.
The actual release behavior of an EC granule product, however, depends on the complete formulation and coating system. Crospovidone alone should not be described as providing enteric release.
Quality and performance of Crospovidone EC Granules can involve several characteristics, depending on the finished product specification:
Numerical values for these properties should be taken from the approved product specification or certificate of analysis.
For an enteric-coated granule system, release performance is generally evaluated through appropriate dissolution testing using an acidic stage followed by a suitable buffer stage. The exact test conditions and acceptance criteria depend on the finished formulation, coating system and applicable pharmacopoeial or customer specification.
Because the crospovidone monograph does not establish a universal enteric dissolution specification for “EC Granules,” product-specific dissolution values should not be invented or presented as standard crospovidone specifications.
Crospovidone EC Granules may be considered for pharmaceutical formulation development involving:
The final use depends on the composition and validated performance of the finished product.
Crospovidone is an established pharmacopoeial pharmaceutical excipient. The current USP-NF monograph identifies the material as a water-insoluble synthetic cross-linked homopolymer of N-vinyl-2-pyrrolidone with CAS Number 9003-39-8 and nitrogen content of 11.0%–12.8% on the dried basis. USP further identifies Type A and Type B materials according to particle size.
Crospovidone is described by USP as a crosslinked polymer and by FCC as a white to off-white, hygroscopic, free-flowing material that is insoluble in water and other common solvents. These descriptions relate to the underlying excipient and should not automatically be applied to a finished enteric-coated granule product whose appearance may depend on the coating system.
Where USP/NF, BP or Ph. Eur. compliance is claimed for the finished material, the claim should correspond to the actual grade, manufacturing controls and current applicable specification.
Crospovidone EC Granules can be evaluated for use in enteric-protected oral formulations, multiparticulate dosage systems, capsule-filled granules and other pharmaceutical formulation platforms where controlled protection and subsequent release are required.
The final performance depends on the active ingredient, excipient composition, coating polymer, coating process, coating weight gain, particle size and dissolution requirements.
Crospovidone EC Granules combine a cross-linked polyvinylpyrrolidone-based excipient with an enteric-coated granule presentation where such a finished product is specifically manufactured and controlled. Crospovidone has CAS Number 9003-39-8 and polymeric formula (C₆H₉NO)ₙ and is recognized in the USP-NF as a water-insoluble cross-linked homopolymer of N-vinyl-2-pyrrolidone.
For commercial Crospovidone EC Granules, finished-product characteristics such as coating composition, coating weight gain, particle-size distribution and dissolution profile should always be stated according to the actual approved specification or CoA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.4% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0–8.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |