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Biomedical subjects

M Dittgen

Publications and source records attributed to M Dittgen.

At least 19 recordsLinked to original sources

Adhesive backing foil interactions affecting the elasticity, adhesion strength of laminates, and how to interpret these properties of branded transdermal patches.

Standard tensile strength and peel adhesion tests were carried out to investigate interactions of pressure-sensitive adhesives (PSAs) with several backing foils used for transdermal patches. Seven branded transdermal patches (Alora, Cutanum, Estraderm MX 50, Estraderm TTS 50, Fem7 -50 micrograms, Menorest, Oesclim) were included in the investigation. Their skin adhesion measured in several clinical trials was compared with the results of the laboratory measurements according to PSTC-1 (Peel Adhesion for Single Coated Tapes 180 degrees Angle, Pressure Sensitive Tape Council, Illinois, 1996), such as Young's modulus at 3% elongation and peel adhesion to stainless steel. Data obtained for the PSA-coated backings (laminates) show increasing elasticity with increasing PSA thickness. Interactions of PSAs with backing foil became evident in significant changes in Young's modulus by low PSA thickness, as seen for the silicone adhesive. The Young's moduli of the laminates were found to be influenced not only by the elasticity of the backing foil but also by the chemical structure of the PSA. There was no correlation between the elasticity and peel adhesion of both the laminates and the branded patches. Likewise, for the branded patches the peel adhesion to stainless steel does not correlate with skin adhesion values obtained from clinical trials. The Young's modulus of the branded patches was between 4 N/mm2 (Oesclim) and 501 N/mm2 (Fem7). For the branded transdermal patches no correlation was found between Young's modulus and both the peel force on stainless steel and the skin adhesion reported in studies.

Adhesives↗

Evaluation of an oral pulsatile delivery system for melatonin in humans.

Using melatonin (MT) as a circadian synchroniser in humans to treat a variety of rhythm disorders, it is desirable to develop controlled-release dosage forms that deliver MT in accordance with its endogenous secretory pattern as well as preparations that release MT in a pulsatile way. In this paper we describe two oral pulsatile dosage forms containing 10 mg MT each (capsules B and C) and a fast-release form containing 5 mg MT (capsule A) studied in a randomised single-dose, threefold cross-over study in 15 healthy male volunteers. The concentrations of both MT in serum and its main metabolite 6-sulfatoxymelatonin (aMT6s) in urine were analysed by means of specific radioimmunoassays up to 10 h p.a. of the MT preparations. Mean peak concentrations of MT in serum were reached between 0.5 h and 0.75 h (Cmax[1] pmol/ml): 20.7 (A), 16.4 (B), 9.7 (C). The capsules B and C released a second MT pulse after about 3.5 h with Cmax[2] of 13.0 and 17.5 pmol/ml, respectively. Dose proportionality for the MT preparations studied was calculated by determining the AUC0-infinity (pmol/ml.h): 18.4 (A), 36.1 (B), 42.4 (C). The terminal serum half-lives of MT ranged between 0.64 and 0.84 h. The time course of the renally excreted aMT6s correlated with that of changes in MT serum concentrations.

Adult↗

[The effect of bioadhesiveness of viscous solutions with naphazoline hydrochloride on the elimination of the drug from the eye of swine].

Solutions of sodium carboxymethylamylopectine, tragant, hydroxyethylcellulose, polyvinylalcohol, polyacrylic ester D 339, polyacrylic ester D 340 and polyacrylic acid, all of the same viscosity and with the same concentration of naphazoline hydrochloride, were applied on the isolated eye of pig. After sink the eye in a solution of sodium chloride the elimination of the drug from the eye was investigated. The results were compared with the bioadhesion of the viscous solutions measured ex vivo on the intestine of pigs. There were correlations between the eliminated mass after 5 min, after 30 min and the bioadhesion. Furthermore the calculated initial elimination constant was indirect proportional to the bioadhesion. The elimination of the drug between 5 and 30 min was independent on the bioadhesion.

Adhesiveness↗

[The effect of mucous excipient concentration on bioadhesion ex vivo].

The bioadhesion of aqueous solutions of polyacrylics (1-3), hydroxyethylcellulose (4), sodium carboxymethylamylopectin (5), polyvinylalcohol (6) and tragant (7) was investigated using a tensiometer and fresh intestine of pigs. It was dependent on the concentration of the excipient as described by a quadratic equation and found in the maximum from 244 Pa (7) to 554 Pa (4). The maximum of bioadhesion corresponds to the concentration of the excipient from 0.15% (2) to 23.7% (4) and to the viscosity of the solutions from 0.11 Pa.s (3) to 3.6.10(6) Pa.s (4). There was not a correlation between the viscosity and the bioadhesion.

Adhesiveness↗