The effect of food on the in vivo behaviour of a novel sustained release formulation of tiaprofenic acid

Wilding, Ian R.; Davis, S.S.; Sparrow, Robert; Bloor, J. R.; Hayes, G.; Ward, G.T.

doi:10.1016/0378-5173(82)90018-7

Cited by 10 publications

(18 citation statements)

References 14 publications

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“…However, eight data from women subjects from two studies [14,28] fulfilled all other criteria and were included in analysis. Inclusion of these data was statistically justified for each study separately and is given in Section 3.3.1.…”

Section: Resultsmentioning

confidence: 99%

“…Therefore, it was presumed that unreported densities from studies included in the MLR model were inside the range of 1.0 --1.5 g/cm 3 and referred to as normal density. This presumption was done for eight studies [10,11,13,14,28,32,34,35].…”

Section: Mlr Analysis 331 Data Preparationmentioning

confidence: 99%

“…In total, 132 individual t 50 values were collected from 11 studies [10,11,[13][14][15]17,28,[32][33][34][35]; the distribution of values is presented in Figure 2. To achieve a normal distribution of residuals and a better fit of the MLR model, the dependent variable t 50 was logarithmically transformed (with logs to the base 10).…”

Section: Mlr Analysis 331 Data Preparationmentioning

confidence: 99%

“…A comparison between mean pellet t 50 values in fasted and fed stomach states or after light or heavy breakfasts was evaluated using the paired [13] or independent sample [10] t-test. The paired sample t-test was also employed for analyzing the pellet t 50 values observed in a fasted stomach state or after light or heavy breakfasts investigated in a joint study [14]. The nonparametric Wilcoxon signed-rank test on the parameter t 50 was used for comparing GE times of a meal and of pellets [15].…”

Section: Introductionmentioning

confidence: 99%

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Analysis of factors influencing gastric emptying of pellets in a fed state

Bürmen

Locatelli

Mrhar

et al. 2015

Expert Opinion on Drug Delivery

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Section: Resultsmentioning

confidence: 99%

Section: Mlr Analysis 331 Data Preparationmentioning

confidence: 99%

Section: Mlr Analysis 331 Data Preparationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Analysis of factors influencing gastric emptying of pellets in a fed state

Bürmen

Locatelli

Mrhar

et al. 2015

Expert Opinion on Drug Delivery

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show abstract

“…These problems can be overcome by the incorporation of a non-radioactive tracer with subsequent radiolabelling by neutron activation (Parr et al 1987;Digenis et al 1990;Hardy et al 1991a;Wilding et al 1992c). Two materials, samarium-152 oxide and erbium-170 oxide are commonly used as tracers.…”

Section: Example 2: Evaluation Of An Enteric-coated Naproxen Tablet Rmentioning

confidence: 99%

Gamma scintigraphy in the evaluation of pharmaceutical dosage forms

Davis¹,

Hardy²,

Newman³

et al. 1992

Eur J Nucl Med

Self Cite

122

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Gamma-scintigraphy is applied extensively in the development and evaluation of pharmaceutical drug delivery systems. It is used particularly for monitoring formulations in the gastrointestinal and respiratory tracts. The radiolabelling is generally achieved by the incorporation of an appropriate technetium-99m or indium-111 labelled radiopharmaceutical into the formulation. In the case of complex dosage forms, such as enteric-coated tablets, labelling is best undertaken by the addition of a non-radioactive tracer such as samarium-152 oxide or erbium-170 oxide followed by neutron activation of the final product. Systems investigated include tablets and multiparticulates for oral administration, enemas and suppositories, metered dose inhalers and nebulisers, and nasal sprays and drops. Gamma-scintigraphy provides information on the deposition, dispersion and movement of the formulation. The combination of such studies with the assay of drug levels in blood or urine specimens, pharmacoscintigraphy, provides information concerning the sites of drug release and absorption. Data acquired from the scintigraphic evaluation of pharmaceutical dosage forms are now being used increasingly at all stages of product development, from the assessment of prototype delivery systems to supporting the product licence application.

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Localization of Drug Release Sites from an Oral Sustained‐Release Formulation of 5‐ASA (Pentasa_®) in the Gastrointestinal Tract Using Gamma Scintigraphy

Hardy¹,

Harvey

Sparrow³

et al. 1993

The Journal of Clinical Pharma

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Release of 5-ASA from a sustained release formulation (Pentasa, Ferring A/S, Copenhagen, Denmark) was monitored with plasma sampling for up to 24 hours in nine volunteers under both fasted and fed conditions. Drug absorption was correlated with location of the sustained-release microgranules in the gastrointestinal tract by gamma scintigraphy. Disintegration of the labeled tablet preparation occurred in the stomach within 20 minutes and acetylated 5-ASA was detectable in the plasma less than 60 minutes after ingestion. No significant differences were detected in either transit times through the small intestine, peak plasma acetylated 5-ASA concentration or lag time to absorption between fasted and fed individuals. Peak plasma concentration of acetylated 5-ASA usually occurred when the microgranules were present in the small intestine or ascending colon. The pharmacoscintigraphic study confirmed that 5-ASA release from the formulation occurred throughout the gastrointestinal tract, and that food effects on the in vivo behavior of the preparation were minimal.

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The effect of food on the in vivo behaviour of a novel sustained release formulation of tiaprofenic acid

Cited by 10 publications

References 14 publications

Analysis of factors influencing gastric emptying of pellets in a fed state

Analysis of factors influencing gastric emptying of pellets in a fed state

Gamma scintigraphy in the evaluation of pharmaceutical dosage forms

Localization of Drug Release Sites from an Oral Sustained‐Release Formulation of 5‐ASA (Pentasa_®) in the Gastrointestinal Tract Using Gamma Scintigraphy

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The effect of food on the in vivo behaviour of a novel sustained release formulation of tiaprofenic acid

Cited by 10 publications

References 14 publications

Analysis of factors influencing gastric emptying of pellets in a fed state

Analysis of factors influencing gastric emptying of pellets in a fed state

Gamma scintigraphy in the evaluation of pharmaceutical dosage forms

Localization of Drug Release Sites from an Oral Sustained‐Release Formulation of 5‐ASA (Pentasa®) in the Gastrointestinal Tract Using Gamma Scintigraphy

Contact Info

Product

Resources

About

Localization of Drug Release Sites from an Oral Sustained‐Release Formulation of 5‐ASA (Pentasa_®) in the Gastrointestinal Tract Using Gamma Scintigraphy