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Bibliografia__________________________________________________________________________

El-Saleh F, Hübscher H, Trofimov S, Muehlenfeld C. Impact of functional-related characteristics (FRCs) of crospovidone on tablet disintegration performance. Pharm Dev Technol. 2025 Jul;30(6):759-771. doi: 10.1080/10837450.2025.2518568. 

Abstract. Crospovidone, a widely used superdisintegrant, exists in two pharmacopeial grades - Type A (coarser particle size) and type B (finer particle size). The differences in particle size among different crospovidone grades lead to variations in functional related characteristics (FRCs), such as hydration capacity and powder flowability. The present study investigates the relative impact of crospovidone FRCs on tablet disintegration time. Multiple lots of different crospovidone grades were evaluated for their particle size distribution, hydration capacity and powder flowability. Subsequently, tablets were prepared from the different lots of crospovidone and evaluated for their disintegration time. Correlation analyses were performed to evaluate the independent effects of FRCs on disintegration time. While initial correlations showed strong interdependence among particle size, hydration capacity, and powder flowability, the decoupling of particle size as the most impacting factor revealed that hydration capacity and powder flowability had no or only limited impact on the tablet disintegration time.

Shaddy SM, Arnold MA, Shilo K, Frankel WL, Harzman AE, Stanich PP, Singhi AD, Yearsley MM, Arnold CA. Crospovidone and Microcrystalline Cellulose: A Novel Description of Pharmaceutical Fillers in the Gastrointestinal Tract. Am J Surg Pathol. 2017 Apr;41(4):564-569. doi: 10.1097/PAS.0000000000000790. 

Abstract. Crospovidone and microcrystalline cellulose (MCC) are pharmaceutical fillers well known in the pulmonary pathology literature. Fillers are inactive substances incorporated into medications to facilitate drug delivery. By examining 545 consecutive gastrointestinal surgical specimens from 302 patients between September 11, 2015 and October 23, 2015, we identified the fillers in 29 specimens from 26 patients. The control group consisted of an equal number of consecutive site-matched specimens collected during this same time. Pertinent clinicopathologic data were analyzed, and 1 case was subject to special stains. To confirm the histologic diagnosis, a variety of fillers and medications common to the patients were processed. The fillers were found in 9% of all patients, and there were no specific clinicopathologic associations. In the gastrointestinal tract, crospovidone is nonbirefringent and has a coral shape with each segment composed of a pink core and purple coat; MCC is brightly birefringent with matchstick shape and clear color. Identical material was seen in the processed crospovidone and MCC powders, as well as oxycodone-acetaminophen and omeprazole tablets. In summary, crospovidone and MCC are common, biologically inert, and they are most often seen in the small bowel. Their presence outside of the luminal bowel may serve as a surrogate marker for perforation. Awareness of their morphology is important to distinguish fillers from parasites, calcifications, and other medications, particularly those linked to mucosal injury. We report the unique histomorphologic profile of these fillers as a helpful diagnostic aide, and caution that the fillers have slightly divergent features when compared with those described in the lung.

Shu T, Suzuki H, Hironaka K, Ito K. Studies of rapidly disintegrating tablets in the oral cavity using co-ground mixtures of mannitol with crospovidone. Chem Pharm Bull (Tokyo). 2002 Feb;50(2):193-8. doi: 10.1248/cpb.50.193. 

Abstract. We attempted the development of rapid oral disintegration tablets by direct compression using co-ground mixture of D-mannitol and crospovidone. The co-ground mixture was prepared with a vibration rod mill. The tablets were formed by compression using a single punch-tableting machine after addition of the co-ground mixture to non-ground D-mannitol, crospovidone and magnesium stearate. Regarding the properties of tablets, hardness and the time of disintegration were measured. The particle diameter and specific surface area of the co-ground mixture were measured. The tablets manufactured from a physical mixture of 30% (w/w) co-ground mixture of D-mannitol and crospovidone (mixed ratio 9 :1) with 65.5% (w/w) of non-ground mannitol, 4% (w/w) of crospovidone, and 0.5% (w/w) of magnesium stearate had good properties for rapidly disintegrating tablets in the oral cavity. They showed the hardness of 4.9 kg and disintegration time of 33 s. We found that adding co-ground mixture of D-mannitol and crospovidone is useful in enhancing hardness of the tablets that could not be achieved by addition of their individually ground mixture. The improvement in the hardness of the tablets was also observed when other saccharides and disintegrants were used. This method was proved to be applicable in the manufacture of tables of ascorbic acid, a water-soluble drug and nifedipine, a slightly water soluble drug; and the dissolution rate of nifedipine from the tablets in water was remarkably improved. The particle sizes of D-mannitol in the co-ground mixture were smaller than that of the individually ground mixture, resulting in a larger specific surface area of the co-ground mixture than that of the individually ground mixture. Therefore, it was presumed that crospovidone acted as a grinding assistant for D-mannitol in the co-grinding process, enhancing the hardness of tablets by increasing the contact area among powder particles.