Quantitative Biopharmaceutics Classification System: The Central Role of Dose/Solubility Ratio

Rinaki, Eleni; Valsami, Georgia; Macheras, Panos

doi:10.1023/b:pham.0000008037.57884.11

Cited by 165 publications

(111 citation statements)

References 35 publications

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“…Several information is available on the level of the toxicity of these compounds. Rinaki et al, (2003) have suggested dose/solubility ratio of biopharmaceutics. Acosta et al, (1985) have given an in vitro approach to the study of target organ toxicity of drug and chemicals.…”

Section: Discussionmentioning

confidence: 99%

Effect of Poly (N-IsoPropylAcrylamide) “PNIPAM” on Hepatic Cells of Swiss Albino Mice, Mus musculus

Aslam

Verma

Roy

et al. 2013

Int J Appl Sci Biotechnol

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The present paper deals with the effect of polymeric compound poly (N-isopropyl acrylamide) "PNIPAM" for their toxicity on hepatic cells. The nanoparticle is a xenobiotic compound that accumulates in the liver for their metabolism. Non-metabolizing xenobiotic compounds such as "PNIPAM" produces anomalies in the hepatic cells. Certain enzymes such as ALT and ALP can be assayed for the hepatocytic toxicity. An attempt has been made to know the toxic effect of "PNIPAM" in a concentration of 0.8mg/ml on the hepatic cells of Swiss Albino mice, Mus musculus. The ALT and ALP analysis were performed through test kits for their quantitative estimation. The histological result shows that several lesions were produced after the introduction of aqueous solution of PNIPAM for an incubation period of 48 hours. The toxicity was confirmed Spectrophotometrically by the assessment of enzyme ALT and ALP. The increased concentration of ALT (55.0 IU/L) and slight decrease in ALP (40.0 IU/L) concentration was responsible for the metabolic alteration and production of hepatocytic anomalies in the mice.

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Section: Discussionmentioning

confidence: 99%

Effect of Poly (N-IsoPropylAcrylamide) “PNIPAM” on Hepatic Cells of Swiss Albino Mice, Mus musculus

Aslam

Verma

Roy

et al. 2013

Int J Appl Sci Biotechnol

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“…8 Acetaminophen (C 8 H 9 NO 2 ) is a crystalline white powder with a bitter taste, is odorless, and has a molecular weight of 151.16. 9,10 About 90% of acetaminophen reacts with 30% sulphate and 60% glucuronide in the liver. These two metabolic pathways can be saturated.…”

Section: Methodsmentioning

confidence: 99%

The effect of acetaminophen nanoparticles on liver toxicity in a rat model

Biazar

Rezayat²,

Montazeri³

et al. 2010

IJN

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Acetaminophen, a pain-reliever, is one of the most widely used medications in the world. Acetaminophen with normal dosage is considered a nontoxic drug for therapeutic applications, but when taken at overdose levels it produces liver damage in human and various animal species. By a high energy mechanically activated method, we produced acetaminophen in a nanometer crystalline size (24 nm). Forty-eight hours after injection of crystalline particles with normal and reduced size of our drug, the effect of liver toxicity was compared by determination of liver transferase enzymes such as alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase (ALT). These enzymes were examined by routine colorimetric methods using commercial kits and pathologic investigations. Statistical analysis and pathological figures indicated that ALT delivery and toxicity in reduced size acetaminophen was significantly reduced when compared with normal size acetaminophen. Pathology figures exhibited reduced necrosis effects, especially the confluent necrosis, in the central part of the lobule in the reduced size acetaminophen samples when compared with the normal samples.

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“…For example, obvious maturation changes are related to the volume increase of luminal fluids, intestinal surface area, and intestinal permeability (12)(13)(14)(15). Administered dose is also fundamentally important, and therefore, there may be a need for a more quantitative, dose-dependent approach to pediatric BCS (16,17). Wu and Benet (18) have proposed an alternative Biopharmaceutics Drug Disposition Classification System which includes the role of metabolism in classifying drugs.…”

Section: Challenges In the Development Of Pediatric Dosage Forms Frommentioning

confidence: 99%

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

Zajicek

Fossler

Barrett

et al. 2013

AAPS J

Self Cite

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Abstract. Despite the fact that a significant percentage of the population is unable to swallow tablets and capsules, these dosage forms continue to be the default standard. These oral formulations fail many patients, especially children, because of large tablet or capsule size, poor palatability, and lack of correct dosage strength. The clinical result is often lack of adherence and therapeutic failure. The American Association of Pharmaceutical Scientists formed a Pediatric Formulations Task Force, consisting of members with various areas of expertise including pediatrics, formulation development, clinical pharmacology, and regulatory science, in order to identify pediatric, manufacturing, and regulatory issues and areas of needed research and regulatory guidance. Dosage form and palatability standards for all pediatric ages, relative bioavailability requirements, and small batch manufacturing capabilities and creation of a viable economic model were identified as particular needs. This assessment is considered an important first step for a task force seeking creative approaches to providing more appropriate oral formulations for children.

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Quantitative Biopharmaceutics Classification System: The Central Role of Dose/Solubility Ratio

Cited by 165 publications

References 35 publications

Effect of Poly (N-IsoPropylAcrylamide) “PNIPAM” on Hepatic Cells of Swiss Albino Mice, Mus musculus

Effect of Poly (N-IsoPropylAcrylamide) “PNIPAM” on Hepatic Cells of Swiss Albino Mice, Mus musculus

The effect of acetaminophen nanoparticles on liver toxicity in a rat model

A Report from the Pediatric Formulations Task Force: Perspectives on the State of Child-Friendly Oral Dosage Forms

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