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[Acute and subchronic experiments on the effects of microcrystalline cellulose on various pharmacological and
Abstract:
The subchronic intravenous application of microcrystalline cellulose (MCC), in a dose of 5 mg/kg twice weekly for 10 weeks, resulted in servere crystal embolism in the lungs of the animals. The clinical parameters were either unchanged (erythrocyte and leucocyte counts, differential blood picture, osmotic resistance of the erythrocytes, total serum bilirubin, serum protein and serum protein fractions) or slightly pathological (hemoglobin content, hematocrit, GOT and GPT). The results from tests of the liver function (by means of bromosulphthaleine clearance) and of the renal function as well as the ophthalmologic examination were not indicative of damaged parenchyma or disturbed microcirculation. Intra-arterial infusions of MCC affected the peripheral muscular blood supply, blood pressure and heart rate.
Insights
Subchronic intravenous microcrystalline cellulose (MCC) caused severe lung crystal embolism in animal models. While some clinical parameters showed minor changes, liver and kidney functions remained unaffected, but intra-arterial MCC impacted circulation.
Area of Science:
- Toxicology
- Pharmacology
Context:
- Microcrystalline cellulose (MCC) is widely used in pharmaceutical formulations.
- Understanding its in vivo effects is crucial for drug safety.
Purpose:
- To investigate the toxicological effects of subchronic intravenous MCC administration.
- To assess the impact of MCC on animal physiology and organ function.
Summary:
- Subchronic intravenous administration of MCC (5 mg/kg, twice weekly for 10 weeks) led to severe pulmonary crystal embolism in animals.
- Erythrocyte and leucocyte counts, osmotic resistance, bilirubin, and protein levels were unchanged.
- Hemoglobin, hematocrit, GOT, and GPT showed slight pathological changes.
- Liver and renal function tests, and ophthalmologic examinations did not indicate parenchymal damage or microcirculation disturbances.
- Intra-arterial MCC infusions negatively affected peripheral muscular blood supply, blood pressure, and heart rate.
Impact:
- Highlights the risk of pulmonary embolism with intravenous MCC.
- Suggests potential cardiovascular and circulatory effects with direct arterial administration.
- Informs safety assessments for pharmaceutical products containing MCC, especially for parenteral routes.