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PubMedDate not supplied

[Parlodel in early combination with levodopa in the treatment of Parkinson disease. Comparison of 2 dosage forms].

In order to compare two titrations of Parlodel in early combination with levodopa in the treatment of Parkinson's disease a multicentre randomized open study was performed with a fast titration in group A (15 mg/day for 3 weeks) and slow in group B (15 mg/day for 5 weeks). 153 patients were included: 77 in group A and 76 in group B. The recommended titration was observed in 76% in group A and 88% in group B, the difference was not significant. The efficacy assessed by the Webster Scale was remarkable and similar in the two groups. This study confirms the additive benefit of bromocriptine on the symptoms and long term complications of levodopa therapy, but no absolute conclusion can be drawn regarding the best titration.

Aged↗
PubMed1994

Relative bioavailability of oral dosage forms of tenoxicam.

The bioavailability of tenoxicam (Ro 12-0068, Tilcotil, CAS 59804-37-4) from an effervescent tablet and an instant milk drink formulation relative to the commercial 20 mg tablet was investigated in a randomized cross-over study. Twelve healthy male volunteers (age 18-35 years; weight 63-95 kg) received on three different occasions a single oral tablet, an effervescent tablet or an instant milk drink (dissolved in water) with each dose containing 20 mg of tenoxicam. The wash-out period between two consecutive treatments was at least 5 weeks. Plasma concentrations after dosing were determined with a specific HPLC method. With the effervescent tablet and the milk drink, maximum concentrations were obtained at the same time (0.5-3.0 h) as with the reference tablet (0.5-4.0 h). Plasma peak concentrations appeared highest after the commercial tablet (mean +/- SD: Cmax 2.8 +/- 0.55 mg/l), but the difference to the effervescent tablet (2.7 +/- 0.41 mg/l) and the milk formulation (2.5 +/- 0.41 mg/l) was negligible. Similar mean elimination half-lives of 73, 77, and 77 h were obtained with the effervescent tablet, the milk drink, and the commercial tablet, respectively. Average bioavailability relative to the tablet was for the effervescent tablet and for the milk drink 96% with a coefficient of variation of 8%. The 90%-confidence intervals of the mean differences between the test and standard preparations in log-transformed AUC0-infinity and Cmax were within 20% around the respective mean parameter value calculated for the standard preparation allowing to conclude bioequivalence of the three oral formulations.

Adolescent↗
PubMed1975

Factors affecting the kinetic assay of nitroglycerin in dosage forms.

Parameters affecting the spectrophotometric kinetic assay for nitroglycerin are described. It is shown that the assay is highly specific; results are not significantly affected by many of the tablet diluents found in commercially-available nitroglycerin tablets. Further, the assay is insensitive to glycerol, nitrate, nitrite and glyceryl dinitrates. This simple, precise and specific nitroglycerin assay is well suited for routine analysis of the drug in commercial tablets and parenteral solutions in hospital pharmacies.

Chemistry, Pharmaceutical↗
PubMed1993

A controlled clinical study on the new topical dosage form of DHEP plasters in patients suffering from localized inflammatory diseases.

In this clinical study the efficacy and the tolerability of a new topical formulation, DHEP plaster, have been evaluated. The plaster consists of an auto-adhesive medicated gauze pad of standard dimensions (10 x 15 cm) containing 180 mg DHEP. The reference drug was a well-known topical drug, diclofenac diethylammonium (DDA) emulgel at 1.16%. Treatments were applied to the affected area for 14 days: DHEP plaster b.i.d. and DDA emulgel q.i.d. A total of 190 patients, affected by various inflammatory diseases, participated in this clinical study. In both treatment groups (DHEP n = 96 patients, DDA n = 94 patients) a clear improvement in the disease and a rapid reduction in pain were observed. The statistical comparison between the two treatments showed a significant difference in favour of DHEP. However a comparison of the results, according to the different diagnoses, did not reveal any statistical significance. Both treatments were well tolerated, although five (DHEP n = 2, DDA n = 3) out of the 190 patients (2.6%) showed transient side effects (pruritus or erythema, both of light intensity).

Administration, Cutaneous↗
PubMed1993

Dissociation constant of chlordiazepoxide in montmorillonite suspension and its pharmaceutical application for a controlled-release dosage form.

The changes in the distribution of the ionic species of a drug due to interactions with a clay surface may have important consequences in drug therapy. The binding of chlordiazepoxide (CDO) into montmorillonite clay, veegum: HV (V), surface was studied under several pH conditions. In vitro drug release behaviour from CDO-V products was investigated. Changes in the partial molar free energy of the ionic species of CDO, delta Gi (i = CDO, CDOH+) as a result of interaction with V were determined by using differential absorbance spectroscopic techniques at 260 and 310 nm. The stronger interaction between the negatively charged clay surface and the protonated species (CDOH+) relative to the parent compound is responsible for the apparent displacement of its pKa value in V suspensions from 4.64 to 5.67. In vitro drug release behaviour from CDO-V product to the simulated gastrointestinal fluids showed a controlled pattern. The in vivo results indicated a prolonged drug effect after the oral administration of drug-clay preparation.

Bentonite↗
PubMed1993

Conventional versus novel conditions for the in vitro dissolution testing of parenteral slow release formulations: application to doxepin parenteral dosage forms.

Parenteral slow release formulations of doxepin in lipid vehicles were prepared in the form of suspensions of doxepin hydrochloride, doxepin pamoate and of poly D,L-lactid and poly D,L-lactid-co-glycolide microspheres containing doxepin hydrochloride. The drug particles or the drug containing microspheres were suspended in the vehicles isopropylmyristate or Miglyol. The dissolution rate of the different doxepin formulations was investigated in two flow through cells, a membrane and a non-membrane system, using either plain buffer or human plasma containing buffer as dissolution media, in order to study the influence of dissolution conditions on dissolution rates. An attempt was made to obtain biorelevant dissolution data. In the membrane system a linear relationship between time and percent drug dissolved during the period of investigation was found. Drug release was very slow and incomplete, especially when buffer was used as dissolution medium. Dissolution data from the nonmembrane system were fitted to monoexponential and biexponential models, respectively. Significant differences were found using different modes of formulation positioning and using the two dissolution media. The most rapid release rates were found when the formulations were spread on glass carriers and plasma was used as dissolution medium. It is suggested that this dissolution procedure has physiological relevance.

Buffers↗
PubMed1977

Stability of aspirin in propoxyphene compound dosage forms.

The stability of aspirin in propoxyphene compound capsules made by three manufacturers, stored under a variety of temperature and humidity conditions, was compared. The cotton packing was removed from 100-capsule bottles, and the containers were stored (capped) under the following conditions: 25 c37 C and 50 C at both high (90%) and low (10%) humidity. No desiccant was removed from the bottles if originally present. The products tested were Darvon Compound-65 (two formulations) (Lilly), SK-65 Compound (Smith Kline & French) and Dolene Compound-65 (Lederle). Under all conditions, the stability of aspirin in the SK-65 Compound product was greater than that of Darvon Compound-65 which in turn was greater than Dolene Compound-65. Further, the rate of aspirin decomposition was greater in the latter product than in the others.

Aspirin↗
PubMed1977

New colorimetric method for folic acid assay in dosage forms.

A new colorimetric method has been developed for estimating folic acid. The British Pharmacopoeial method has been modified to reduce folic acid to 2,4,5-triamino-6-hydroxy-pyrimidine (TAHP), which is treated with ninhydrin to yield a stable purple complex. Participation of 5-amino and 6-hydroxy groups of TAHP in the color reaction with ninhydrin is suggested on the basis of experimental evidence. The color obtained has an absorbance maximum at 555 nm and obeys Beer's law in the concentration range of 4.5 to 45 microng folic acid/ml. The method has been successfully used for assaying folic acid, its tablets, and injections.

Colorimetry↗