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Biomedical subjects

H Möller

Publications and source records attributed to H Möller.

At least 73 records · Page 4Linked to original sources

Regulatory aspects of modified release dosage forms: special cases of dissolution testing using the flow-through system.

More than 30 years have been devoted to characterizing the biopharmaceutical properties of drug products. The numerous tests developed are generally based on two distinct methodologies--a closed system (beaker method) and an open system (flow-through method). Selected methods were finally standardized and described in such pharmacopoeias as Ph. Eur. 2, USP XXII and Ph. Jap. XII. The most common procedures are the paddle and basket methods. An alternative method--the flow--through method--was also introduced into the pharmacopoeias Ph. Eur. 2 and USP XXII. The advantages of the flow-through method are evident with regard to testing and assessing different types of dosage forms and active ingredients of very slight solubility. Changes of testing fluids (e.g. change to the pH) can be easily performed during the test. Another advantage is seen in the positioning of the specimen. Capsules, even when floating initially, or pellets can be tested using the same equipment and require no additional devices such as sinkers. With slight changes to the cell design, the same apparatus can be used for the testing of powders, or even non-solid dosage forms such as suppositories or soft-gelatine capsules. For long-term testing necessary for extended release products, flow-through apparatus offers a considerable number of advantages for routine work. Irrespective of the methodologies used, dissolution tests should be validated with regard to analytical methods, testing conditions and specifications. The validation of the analytical method should follow EC guidelines. Testing conditions should take into account the choice of the correct apparatus, dissolution media and agitation. The results of in vitro dissolution should be validated by in vivo data in an analogous sense. The practical application of flow-through apparatus is presented on the basis of various examples regarding development and batch control. The assessment of in vitro dissolution of biopharmaceutical characterization of drug substances, enteric-coated tablets, controlled release products, suppositories and implants will be discussed.

Biopharmaceutics↗

Ultrastructural localization of actin in normal human skin.

Normal human skin was embedded in Lowicryl K4M. Actin microfilaments were localized by applying a postembedding immunogold technique using the monoclonal anti-actin antibody HHF35. Actin microfilaments are part of the cytoskeleton in muscle and nonmuscle cells. Together with myosin they produce contraction. The antibody labelled myofilaments in smooth muscle arrector pili cells, myoepithelial cells and pericytes. In sweat gland cells the microvilli system, a zone beneath the cytoplasma membrane corresponding to the adhesion belt region, and apocrine decapitation formations showed labelling.

Actins↗

[Long-term course of dyslexia beyond the school years: catamnesis from pediatric psychiatric ambulatory care].

In our follow-up study 12 years after index admission we were able to examine 59 out of 115 male patients who had been diagnosed in our department as dyslexic (mean age: 10.1 years). Spelling skills at follow-up were more than one standard deviation below the norm for the subjects' age (T-value on the RT of only 24). About half of our patients had participated in a specific spelling remediation program lasting more than 6 months, but at follow-up no effect of therapy could be demonstrated. The patients with the higher IQs regressed in spelling less than those with the lower IQs. We assume that the effects of remediation programs do not survive therapy and school for long because later on good spelling is no longer either required or encouraged. Our patients were severely impaired in their school career: Although their average IQ was 112 only 6 out of 59 had completed a college-preparatory program (Abitur), all of them from middle-class families with well-educated parents. Our patients chose occupations corresponding to the type of high school diploma they had, often those requiring practical skills rather than reading or spelling skills. Patients who had completed no more than the nine obligatory years at school were less content with their work than expected. Emotional disorders during the past 6 months were no more frequent than expected. In a self-report about delinquency there was no difference compared to a random sample.

Adolescent↗

Capsaicin enhances allergic contact dermatitis in the guinea pig.

Guinea pigs were sensitized to dinitrochlorobenzene (DNCB) by the intracutaneous route and challenged epicutaneously on the flanks. The intensity of the allergic contact dermatitis was evaluated by inspection and palpation as well as by wet weight determination. With the purpose of diminishing tissue neuropeptides, and substance P in particular, the animals were treated with capsaicin either between induction and challenge, or before sensitization. In comparison with controls, the contact dermatitis was enhanced in both groups of animals treated with capsaicin.

Animals↗

Intradermal testing in doubtful cases of contact allergy to metals.

Among 1670 consecutively patch tested patients an intradermal test with chromium, cobalt and nickel was added in 66 cases. There were three indications for intradermal testing: 1) the patch test reaction at 72 h was difficult to interpret; among 49 patients with one or more doubtful reactions a metal allergy was confirmed in 24 and rejected in 54. 2) ten patients with a negative patch test in spite of a positive history of metal allergy; among these, one was positive to cobalt, two to nickel and the other seven negative. 3) seven patients checked for a previously diagnosed allergy; a metal allergy was confirmed in four. Intradermal testing is recommended for confirmation of doubtful patch test reactions, particularly to disclose false positive reactions to metals.

Chromium↗

Testing a purified lanolin preparation by a randomized procedure.

Patients with a previous contact allergy to lanolin (wool alcohols and/or Amerchol L 101) were patch tested 1 to 4 years later with lanolin allergens, as well as purified anhydrous lanolin contained in a commercial cream. At this retest, only 20 out of 33 patients with a previous contact allergy to lanolin reacted to lanolin allergens, and only 1 to the purified lanolin (as is). None reacted to the commercial cream containing 6% purified lanolin, this being ascertained by patch test as well as by usage test. To avoid bias at reading, patch tests were applied in a randomized computer-based order and read blindly.

Allergens↗

Implantation of orthopaedic devices in patients with metal allergy.

Patients with a contact allergy to chromium, cobalt and/or nickel, patch test verified before implantation of a metallic orthopaedic device, were followed up years later by clinical and radiographic examination as well as with epicutaneous and intracutaneous tests. Eighteen patients had been exposed to an orthopaedic implant for several years (mean 6.3 years) containing a metal to which they were allergic. None had suffered any dermatologic or orthopaedic complications attributable to the contact allergy.

Chromium↗

Some neuropeptides as modulators of experimental contact allergy.

The rôle of some peptides in allergic contact dermatitis was investigated. The neuropeptides: substance P (SP), vasoactive intestinal peptide (VIP) and somatostatin, as well as the SP antagonist spantide, were injected into the same skin sites as the antigen in patients with contact allergy to nickel. The neuropeptides did not influence the eczematous reaction but spantide diminished it. This might speak for a pathogenetic rôle of SP in allergic contact dermatitis.

Analgesics↗

Skeletal involvement in pustulosis palmo-plantaris with special reference to the sterno-costo-clavicular joints.

Skeletal scintigraphy was performed in patients with pustulosis palmo-plantaris. There was an increased isotope uptake in the sterno-costo-clavicular area in 16 of 73 patients (22%). The skeletal involvement was further studied by computer tomography showing seven characteristics (including unilaterality) typical of the disease. Clinically, the arthritis is aseptic and benign, and only 9 of 16 patients with a positive scintigraphy complained of juxta-sternal arthralgia.

Adult↗

Occurrence of substance P, vasoactive intestinal peptide, and calcitonin gene-related peptide in dermographism and cold urticaria.

Substance P (SP), calcitonin gene-related peptide (CGRP), and vasoactive intestinal peptide (VIP) were assayed in lesions and normal skin of patients with dermographism and cold urticaria utilizing suction-induced blisters. There was no difference in SP and VIP concentrations between challenged and control skin of urticaria patients. On the whole, however, the concentration of both neuropeptides, and VIP in particular, was higher in the urticaria patients than in control subjects. CGRP levels were not increased. SP and VIP in blood samples from veins draining challenged skin areas were below the detection limit. It is concluded that SP and VIP may potentiate histamine in wheal formation and thus contribute to the increased reactivity of the skin to trauma and temperature changes in patients with physical urticaria.

Adult↗

Oral hyposensitization in nickel allergy.

In two controlled studies, each including 24 patients with contact allergy to nickel, different protocols were designed in an attempt to diminish the patients' hypersensitivity by oral administration of the antigen. With doses of 5.0 mg nickel sulfate taken once a week for 6 weeks, but not with 0.5 mg daily, the degree of contact allergy was significantly lowered, measured as patch test reactions before and after nickel administration.

Administration, Oral↗

Nickel allergy.

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Dermatitis, Contact↗