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PubMed1984

Effect of aging on hydrocortisone-polyethylene glycol 4000 and hydrocortisone-polyvinylpyrrolidone dispersions.

Dispersions containing 40% hydrocortisone were prepared by the solvent method in polyethylene glycol 4000. Dispersions in polyvinylpyrrolidone were prepared by slow evaporation of solvent (type A) and by fast evaporation of solvent (type B). These dispersions were stored at 25 degrees C for 30 d. Plots of time required for 50% (t50%) and 70% (t70%) of the hydrocortisone dispersion to dissolve (beaker method) versus time were obtained. Hydrocortisone-polyethylene glycol showed no apparent significant change in either dissolution rate, X-ray spectra, or scanning electron micrographs. Type A dispersions showed an increase in dissolution rate up to 8 d. Type B dispersions showed an initial decrease followed by an increase in dissolution rate. The initial decrease in dissolution rate of type B dispersions is due to hydrocortisone crystallizing out of the polyvinylpyrrolidone matrix. The increased dissolution for both types of polyvinylpyrrolidone dispersions was not expected and is for both types of polyvinylpyrrolidone dispersions was not expected and is explained by an increased proportion of the high-energy amorphous component, based on X-ray spectra. Other possibilities such as the presence of polymorphic forms of hydrocortisone and/or reduction in particle aggregation could not be discounted.

Chromatography, Thin Layer↗
PubMed2001

Hydrocortisone suspension and hydrocortisone tablets are not bioequivalent in the treatment of children with congenital adrenal hyperplasia.

In July 1998, Cortef oral suspension (Pharmacia & Upjohn) was reformulated changing the suspending agent tragacanth to xanthan gum. We subsequently observed suboptimal control of hormone levels in a group of children with classic congenital adrenal hyperplasia, despite increasing doses of Cortef suspension and stringent instructions to parents regarding shaking of the bottles of medication. Nineteen children receiving Cortef and fludrocortisone therapy were changed to hydrocortisone tablets and fludrocortisone, with a 10 percent reduction in hydrocortisone dose. A significant decrease in 17-hydroxyprogesterone (235 +/- 120 vs. 27 +/- 7 nmol/L; p</=0.001) and androstenedione (18.9 +/- 18.0 vs. 3.5 +/- 3.5 nmol/L; p=0.002) was observed 4-6 weeks later. Twenty-one percent (4/19) had 17-hydroxyprogesterone and androstenedione levels at or below the detection limit of the assay. Despite a significant reduction in glucocorticoid dose (19.6 +/- 4.7 vs. 17.6 +/- 3.9 mg/M(2)/day; p<0.001), eight children experienced significant weight gain and appetite increase, three experienced trouble sleeping, four experienced moodiness, and three developed hypertension requiring a decrease in fludrocortisone therapy. Hydrocortisone dose was further decreased to 15.2 +/- 2.6 mg/M(2)/day with resolution of symptoms. We conclude that Cortef suspension and hydrocortisone tablets are not bioequivalent and the reformulated form of hydrocortisone oral suspension was inadequate in the control of children with congenital adrenal hyperplasia. Cortef suspension has been recalled as a result of these data.

17-alpha-Hydroxyprogesterone↗
PubMed1985

Solution kinetics of a water-soluble hydrocortisone prodrug: hydrocortisone-21-lysinate.

Hydrocortisone-21-lysinate was synthesized as an amino acid prodrug of hydrocortisone to serve as a substrate for brush border aminopeptidases. This strategy was developed to demonstrate that an improvement in oral absorption could be obtained through reconversion in vivo. The aqueous stability of hydrocortisone-21-lysinate was studied over the pH range 3-8 at 25 degrees C. Reversible acyl migration of the lysine group between the 21- and 17-position hydroxyl groups was observed as well as hydrolysis. The observed half-life for direct hydrolysis of hydrocortisone-21-lysinate is 40 d at pH 3 and 30 min at pH 7. The relative instability at pH 7 is probably due to electrostatic stabilization of the negatively charged tetrahedral intermediate by the protonated amino groups.

Chromatography, High Pressure Liquid↗
PubMed1984

Hydrocortisone alone vs hydrocortisone plus aminoglutethimide: a comparison of the endocrine effects in postmenopausal breast cancer.

The endocrine effects of replacement doses of hydrocortisone in postmenopausal women with advanced breast cancer were compared with the same doses of hydrocortisone plus aminoglutethimide. Fifteen patients received aminoglutethimide (AG) 250 mg three times a day plus hydrocortisone (HC) 20 mg twice a day for 2 weeks, then AG was increased to 250 mg four times a day. Another 13 patients received HC alone for 2 weeks, then AG was added. HC alone significantly suppressed oestrone (75% of baseline) and oestradiol (50% of baseline). Addition of AG to these patients produced further oestrone suppression (50% of baseline) significantly greater than HC alone. HC alone suppressed dehydroepiandrosterone sulphate as much as AG + HC. delta 4-androstenedione (delta 4A) and dehydroepiandrosterone (DHA) were suppressed by HC alone. Addition of AG produced a rise of delta 4A to basal levels. These results show that 3-beta-ol de hydrogenase is not induced by AG. AG plus HC together from day 1 produced significantly greater oestrone suppression (50% of baseline) than HC alone. Because high-dose steroids may induce aromatase and replacement doses produced marked peripheral endocrine effects, the use of replacement hydrocortisone should be reassessed in advanced breast cancer.

Aminoglutethimide↗
PubMed1994

IgG antibodies and early intradermal reactions to hydrocortisone in patients with cutaneous delayed-type hypersensitivity to hydrocortisone.

Seven of 25 patients with cutaneous delayed-type hypersensitivity to hydrocortisone had an immediate reaction following the intradermal injection of hydrocortisone sodium succinate. Using an ELISA method, we found that these patients had significantly increased levels of IgG antibodies to hydrocortisone when compared with normal blood donors (P < 0.005) and nickel-allergic patients (P < 0.05). We suggest that these patients are at risk of developing type III and possibly type I reactions following the systemic administration of hydrocortisone and that, if needed, an alternative systemic corticosteroid should be used, for example betamethasone or dexamethasone.

Antibodies↗
PubMed1991

Chlorocoulometric determination of hydrocortisone and hydrocortisone acetate.

A chlorocoulometric method for the determination of small amounts of hydrocortisone and hydrocortisone acetate is presented. The method is simple and rapid, the results obtained are accurate and reproducible. It can be successfully applied to the determination of hydrocortisone and hydrocortisone acetate in pharmaceutical formulations.

Electrochemistry↗
PubMed1986

Regulation of hydrocortisone binding sites by hydrocortisone in human bone marrow fibroblasts.

The incubation of human bone marrow fibroblasts with hydrocortisone (10(-7) M) produces a time-dependent depletion of hydrocortisone-binding sites. This effect is glucocorticoid-specific, since glucocorticoid agonists cause depletion to the same extent as hydrocortisone. After withdrawal of the hormone from the incubation medium, cells are able to replenish their complement of receptor. The existence of this down-regulation process may represent a protective mechanism against the partial proliferative inhibitory action of glucocorticoids for bone marrow fibroblasts and also a stimulus for differentiation to adipocytes.

Binding Sites↗
PubMed1987

A randomized phase II trial of aminoglutethimide and hydrocortisone versus combined aminoglutethimide, hydrocortisone and fluoxymesterone in advanced breast cancer.

Fifty postmenopausal women with advanced breast cancer were included in the following randomized phase II trial: 25 patients received aminoglutethimide 1000 mg and hydrocortisone 40 mg daily. Twenty-five patients received aminoglutethimide 1000 mg, hydrocortisone 40 mg and fluoxymesterone 20 mg daily. The two groups of patients were comparable in respect to the most important pretreatment characteristics. The majority of patients in both groups had bone lesions. There was a history of response to tamoxifen in all the cases and 17 patients had positive estrogen and progesterone receptors. The evaluation of response was based on the system adopted by the UICC. In the aminoglutethimide-hydrocortisone group, 16 (64%) patients obtained a partial remission, 3 (12%) remained stable and 6 (24%) had progressive disease. In the combination treatment group, 17 (68%) patients obtained a partial remission, 3 (12%) remained stable and 5 (20%) developed progressive disease. The median duration of partial remission and stabilization of the disease was 9 and 7 months respectively in both groups.

Adult↗
PubMed1981

[Studies on toxicity of hydrocortisone 17-butyrate 21-propionate -1. Acute toxicity of hydrocortisone 17-butyrate 21-propionate and its analogues in mice, rats and dogs (author's transl)].

The acute toxicity of hydrocortisone 17-butyrate 21-propionate (HBP), hydrocortisone 17-butyrate (HB17) and hydrocortisone 21-butyrate (HB21) were investigated by three administration routes (s.c., i. p. and p. o.) in mice, rats and dogs. In the case of HBP, LD50 by oral administration was the highest, and followed by subcutaneous and intraperitoneal administration in mice and rats. And LD50 of HB17 and HB21 were not different from HBP in mice by subcutaneous administration. The depression of spontaneous movement and respiratory rate, ptosis, larcrymation and the collapse were commonly observed in all drugs, and it was independent of administration routes. The autopsy revealed the atrophy of thymus, spleen and adrenal glands, the supprative nodules of heart and liver and the ulcers of alimentary tract in mice and rats. But the changes observed in mice and rats were recognized when 1000 mg/kg of HBP was administered to dogs subcutaneously. Many of these changes were common to glucocorticoids, and the LD50 of HBP was rather high compared with other synthetic steroids; therefore, HBP was among less toxic steroid.

Administration, Oral↗
PubMed1989

[Effectiveness of intra-articular dimexide in combination with hydrocortisone and hydrocortisone in patients with juvenile rheumatoid arthritis].

A course of 4-5 intra-articular injections was given to 25 children aged 4-15 years with juvenile rheumatoid arthritis: 20% dimexide++ solution in combination with hydrocortisone (2 ml) was administered into the right knee joint and hydrocortisone (12.5 mg) into the left knee joint once a week. Dimexide++ solution combination with hydrocortisone proved to be most effective: all signs of inflammation subsided, the joint function was restored and there were no untoward reactions.

Arthritis, Juvenile↗
PubMed1990

Treatment of stage D2 prostatic cancer refractory to or relapsed following castration plus oestrogens. Comparison of aminoglutethimide plus hydrocortisone with medroxyprogesterone acetate plus hydrocortisone.

A total of 59 patients with advanced prostate cancer relapsed from or refractory to castration plus oestrogen were treated in a randomised trial comparing 1000 to 1250 mg aminoglutethimide + 40 mg hydrocortisone (AG + HC) with 500 mg medroxyprogesterone acetate + 40 mg hydrocortisone (MPA + HC). A significantly higher objective response rate and better symptomatic control was noted in patients treated with AG + HC (31%) compared with those treated with MPA + HC (3%). The median time to treatment failure was also significantly longer for patients treated with AG + HC. These findings suggest a role for AG in the treatment of advanced prostate cancer. While both second-line hormone treatment regimens resulted in significant suppression of adrenal androgen secretion, the differences in response rate could not be explained by alterations in peripheral blood hormone levels. AG in high doses may have cellular effects which require further study.

Aged↗
PubMed1980

Treatment of distal ulcerative colitis (proctosigmoiditis) in relapse: comparison of hydrocortisone enemas and rectal hydrocortisone foam.

Thirty patients with distal colitis (proctosigmoiditis) in relapse were randonly allocated to twice daily treatment with traditional aqueous hydrocotrisone enemas (Cortenemas) or a suspension of hydrocortisone in an inert foam base (Colifoam). Each treatment contained the same amount of hydrocortisone. Clinical, sigmoidoscopic, and histological response was assessed after two weeks. Both agents were effective, and broadly similar in terms of objective improvement, but subjective improvement was greater with the foam preparation, and several patients expressed a preference to this mode of treatment.

Administration, Topical↗
PubMed1984

Hydrocortisone 17-butyrate (Locoid) 0.1% cream versus hydrocortisone (Uniderm) 1% cream in the treatment of children suffering from atopic dermatitis.

A randomized, double-blind, left-right study to compare the therapeutic efficacy of hydrocortisone 17-butyrate (Locoid) 0.1% cream with hydrocortisone (Uniderm) 1% cream was performed in forty children suffering from atopic dermatitis. The medications were applied to symmetrical bilateral skin lesions twice daily for a maximum of 4 weeks or until complete clinical clearance of such lesions had occurred. Complete clearance of skin symptoms was found in 36% of the Locoid-treated sides and in 23% of the Uniderm-treated sides following 2 weeks of therapy and in 60% and 30%, respectively, after 4 weeks of treatment. This difference in clearance rate after 4 weeks between both preparations was significantly in favour of Locoid cream. The expressed preferences of patients/parents and investigator were also significantly in favour of Locoid cream, both after 2 and 4 weeks. No serious side-effects were reported during this study. It is concluded that Locoid cream is significantly superior to Uniderm cream in the treatment of atopic dermatitis in children.

Administration, Topical↗
PubMed1990

Problems with clinical trials in general practice--a double-blind comparison of cream containing miconazole and hydrocortisone with hydrocortisone alone in the treatment of intertrigo.

A double-blind comparative study between 1% hydrocortisone cream and a combination of 1% hydrocortisone cream and 2% miconazole cream has highlighted some of the problems with this type of research in general practice. The collection of adequate patient numbers within a predefined time scale proved a major problem. However, the study demonstrated the safety and efficacy of both these preparations in the treatment of intertrigo.

Double-Blind Method↗
PubMed1981

[The hydrocortisone test (400 mg hydrocortisone test) for the study of the "recirculating" lymphocyte population. Tests of patients with lymphoproliferative diseases and solid neoplasms].

The hydrocortisone test has been performed on 20 patients with lymphoproliferative disease (MH, LNH, CLL, MM, BMG) and 12 patients with solid neoplasm to study the "recirculating" lymphocytic population (mainly T lymphocytes with "helper" function). Therefore, as proposed by Fauci and Dale, we counted the basal venous blood lymphocytes in the morning after fasting and then 4 h after the administration of hydrocortisone 400 mg. While the test did not appear to be statistically modified in patients with solid neoplasms as compared to normal controls, it appears particularly compromised in lymphoproliferative diseases, but with different values in each disease. The results are discussed on the basis of lymphocytic kinetic data.

Adult↗
PubMed1976

Simultaneous analysis of hydrocortisone and hydrocortisone phosphate by high-pressure liquid chromatography: reversed-phase, ion-pairing approach.

The reversed-phase, ion-pairing approach to high-pressure liquid chromatography was applied to the simultaneous analysis of hydrocortisone and its phosphate ester in laboratory-prepared samples and injectable solutions. Results of this technique were evaluated and compared with results of the official procedure.

Chromatography, High Pressure Liquid↗
PubMed1984

Effect of hydrocortisone on immune system of the lizard, Chalcides ocellatus. I. Response of lymphoid tissues and cells to in vivo and in vitro hydrocortisone.

A single dose of 1 mg/g body weight of hydrocortisone acetate (HC) administered intraperitoneally to adult lizards, Chalcides ocellatus induced rapidly a reduction of about 85% of thymic lymphocytes. Histological evidence indicated that cortical, as well as, medullary thymocytes are sensitive to HC exposure. Around 40-50% of lymphocytes in peripheral blood (PB) and spleen were depleted at 3-7 days post-HC injection; such depletion durated about 4 weeks for PB but was rather temporary in spleen. Increase in number of bone marrow (BM) lymphocytes was negligible and transient and could by no way account for the dramatic cell losses in the different lymphoid tissues. The findings thus suggested that HC-mediated lymphocyte depletion in lizards is not attributable to redistribution between the different lymphoid compartments but rather to destruction. In direct conformation, lymphocytes were readily lysed in vitro by 10(-3)M HC, thymocytes being more vulnerable greater than PB greater than spleen greater than BM lymphocytes.

Animals↗
PubMed1987

Endocrine effects of aminoglutethimide plus hydrocortisone versus effects of high dose of hydrocortisone alone in postmenopausal metastatic breast cancer.

Aminoglutethimide (Ag) has been used in different dosages with and without combined treatment with glucocorticoids for the suppression of peripheral plasma levels of steroidal hormones. In the present work we have estimated changes in peripheral steroid levels after 3 days of adrenal suppression with a 'physiological' daily dose of 40 mg hydrocortisone (H). Subsequently Ag (1000 mg daily) was added or the dose of H was doubled in order to study the efficacy of the suppression of oestradiol by these conditions during a 6-week period. Sixteen postmenopausal patients with evaluable and measurable progressive breast cancer were selected for the initial treatment, thereafter Ag was added in eight patients, while the other eight patients continued on H with a double dose. Administration of 40 mg H daily during the first 3 days caused a significant decrease of plasma oestradiol (P less than 0.01), androstenedione (P less than 0.01) and DHEA-S (P less than 0.05). Basal plasma cortisol levels increased and the diurnal rhythm disappeared. These observations suggest suppression of adrenal function by the exogenous cortisol. Prolonged treatment with a higher dose of H (80 mg daily) caused further suppression of androstenedione (P less than 0.01) but not of oestradiol. The addition of 1000 mg of Ag to H had no further significant effect on plasma oestradiol levels either. The main difference between the effects of the two treatment modalities was in the levels of androgens. The group treated with H alone showed long-term significant suppression of both androstenedione and DHEA-S, while in the group treated with the combination of H + Ag a further pronounced suppression of DHEA-S and elevation of androstenedione was found. Finally, there was a significant difference between SHBG levels in the two groups at day 42. The increased levels of SHBG in the H + Ag-treated group might lower the 'free' oestradiol concentration. It is concluded that both drugs have different effects on the plasma levels of peripheral steroids. On theoretical grounds, the combination of H + Ag might be preferable, because 'free' oestradiol plasma levels may be lowest after this treatment. However, a direct correlation with clinical effects still remains to be proven.

Aged↗