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Biomedical subjects

H Jünger

Publications and source records attributed to H Jünger.

14 recordsLinked to original sources

[Experience in scaling up the film coating process for theophylline sustained-release pellets in mass production].

The scale-up of the film coating process for the production of Bronchoretard pellets (theophylline, CAS 58-55-9) is an example for the successful setup of a modern production technology designed to meet the increasing GMP requirements while taking into consideration ecological and economical aspects. This technology provides a reduction in polymer losses on drying from approx. 20% to under 5% and a distinct improvement in the reproducibility of the in vitro dissolution profiles. Double batch sizes and higher spray rates allow for a substantially higher batch turnover. A production line installed exclusively for Bronchoretard pellets and specific process optimization measures resulted in considerably lower lag-times of the equipment.

Anti-Asthmatic Agents↗

Stability behaviour of molsidomine-containing pellet formulations.

Molsidomine in mixtures with different inactive ingredients has been subjected to a stability test. The fingerprint chromatogram obtained by HPLC with diode-array detection of mixtures of molsidomine with povidone 25 revealed decomposition products; the detection wavelength of 210 nm resulted in easy detection of the degradation products. Molsidomine-containing pellets were manufactured according to a compact procedure and by applying the active ingredient to placebo pellets. Compared with the nonpareil pellet formulations, compact pellets have a considerably higher water content and undergo decomposition of the active ingredient after storage for 50 months under different conditions. It is assumed that the decomposition of molsidomine is accelerated by the peroxide found in povidone.

Chemistry, Pharmaceutical↗

Oral supplements in HIV-infected patients with chronic wasting. A prospective trial.

AIM: Supplementation with polymeric formula diet was evaluated as second step of a nutritional intervention program for malnourished, but otherwise clinically stable HIV-infected patients. PATIENTS AND METHODS: 34 patients with weight loss, without opportunistic infections, diarrhea or fever, not responding to nutritional counselling as first intervention, were included. They were given 1000 kcal per day as polymeric formula. If further weight loss occurred, dose was increased to 1500 kcal per day. Nutritional status was determined by body weight and bioelectrical impedance. RESULTS: After four weeks, 7/34 patients already stopped intake. Only 10/34 patients completed three months of treatment. The average intake during three months was 496 +/- 363 kcal/d. Reasons for drop-out were intervening clinical deterioration in eight, early improvement in six, but intolerance or loss to follow-up in ten patients. On average, body weight did not change. Intake of formula diet and weight changes were not correlated. CONCLUSION: Oral supplements are a feasible, cost-effective and safe treatment of malnutrition, but they are accepted only for short time and in limited amount. To estimate efficacy of this treatment, clinical reasons for malnutrition must be considered. More effective nutritional treatments are needed for chronically malnourished HIV infected patients.

Adult↗

[Bioavailability of theophylline in a new oral sustained-release preparation (author's transl)].

On the basis of biopharmaceutic-pharmacokinetic and galenic aspects a new sustained-release preparation of theophylline according to the "divided-dose" principle was developed. The technological procedure used allows a reproducible manufacture of a stable product with narrow limits of pharmaceutical quality. The bioavailability of the sustained-release pellets in a dose corresponding to 350 mg active principle is examined in comparison to an aqueous solution or retard-tablet formulation on the marked (containing 260 mg drug/dose), respectively, after single or multiple dose administration to 7 healthy volunteers. The relative bioavailability of the new formulation is about 100%. During chronic application the controlled drug delivery from the sustained-release pellets warrants only slight fluctuations of plasma levels by avoiding peak concentrations. Formulations with a dosage of 200, 350 or 500 mg, respectively, allow adaptation of continuous plasma levels in the therapeutic range between 5--20 micrograms/ml according to the therapeutic necessities of a patient.

Adult↗

[Cement ulcers].

It is told of a toxic contact dermatitis of a mason with hitherto intact skin. One is searching for the reason of this rarely appearing skin damage by taking into consideration the chemical process during the cement preparation as well as in the following working process. The low number of cases known so far in relation to the millions of tons of processed cement on the one hand and the serious professional consequences for the persons concerned on the other have caused us to discuss once again the causal correlations in this essay.

Adult↗