Comparative Pharmacokinetics of Two Fast-Dissolving Oral Ibuprofen Formulations and a Regular-Release Ibuprofen Tablet in Healthy Volunteers

, , Whitehall-Much GmbH, Münster, Germany; , , , Whitehall International, Havant, Hants, England

Clin Drug Invest. 2001;21(1)

Conclusion

Bioequivalence between 200mg tablets of ibuprofen lysinate and a new 200mg soft gelatin capsule was demonstrated. In accordance with previous results, this study confirmed again the pharmacokinetic differences between standard ibuprofen acid tablets and fast-dissolving formulations. The new formulation is likely to show clinical benefit as an ibuprofen preparation in patients with acute pain because of its plasma concentration versus time profile, resulting fromthe rapid release of the already dissolved ibuprofen from the soft gelatin capsule.

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Funding information

This study was supported by a grant from Whitehall International.

Table I. Pharmacokinetic parameter values for ibuprofen in 26 healthy volunteers following administration of 2 x 200mg of ibuprofen as sugar-coated tablets (Advil®), soft gelatin capsules (Spalt-Liqua®) or ibuprofen lysinate tablets (Nurofen® Advance). Values are arithmetic means±SD
Parameter and units	Sugar-coated tablet	Soft gelatin capsule	Ibuprofen lysinate
C_max (mg/L)	31.98±6.483	49.69±8.397	43.25±6.663
t_max (h)	1.30±0.747	0.541±0.173	0.542±0.160
AUC_t (mg/L h)	108.0±18.33	107.4±17.94	108.2±22.11
AUC_infinity (mg/L h)	109.3±18.50	108.9±18.16	109.7±22.36
t_1/2z (h)	2.02±0.296	1.98±0.253	2.01±0.274
z (1/h)	0.349±0.0462	0.355±0.0418	0.351±0.0464
ln C_max	3.444±0.2114	3.892±0.1678	3.755±0.1615
ln AUC_t	4.666±0.1859	4.662±0.1759	4.664±0.2056
ln AUC_infinity	4.679±0.1854	4.676±0.1756	4.677±0.2059

AUC_t = area under the plasma concentration-time curve from zero to the time of the last measurable concentration; AUC_infinity = area under the plasma concentration-time curve from zero to infinity; C_max = maximum observed plasma concentration; t_max =time to reachC_max; t_1/2z = terminal elimination half-life; _z = terminal elimination rate constant.

Table II. Statistical comparison of logarithmically transformed pharmacokinetic parameters for ibuprofen following administration of 2 x 200mg of ibuprofen as sugar-coated tablets (Advil®; treatment A), soft gelatin capsules (Spalt-Liqua®; treatment B) or ibuprofen lysinate tablets (Nurofen® Advance; treatment C). The ratios are based on the least-square means from the analysis of variance
Parameter	B versus A		B versus C
Parameter	mean ratio (%)	90% CI (%)	mean ratio (%)	90% CI (%)
ln C_max	157.1	146.4-168.6	114.2	106.4-122.5
ln AUC_t	99.2	96.3-102.2	99.3	96.4-102.3
ln AUC_infinity	99.4	96.5-102.3	99.3	96.5-102.

AUC_t = area under the plasma concentration-time curve from zero to the time of the last measurable concentration; AUC_infinity = area under the plasma concentration-time curve from zero to infinity; CI = confidence interval; C_max = maximum observed plasma concentration.

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