A highly efficient, selective and specific method for simultaneous quantitation of triprolidine and pseudoephedrine in human plasma by liquid chromatography-ion trap-tandem mass spectrometry coupled with electro spray ionization (LC-ESI-ion trap-tandem MS) has been validated and successfully applied to a clinical pharmacokinetic study. Both targeted compounds together with the internal standard (gabapentin) were extracted from the plasma by direct protein precipitation. Chromatographic separation was achieved on a C(18) ACE((R)) column (50.0mmx2.1mm, 5mum, Advance Chromatography Technologies, Aberdeen, UK), using an isocratic mobile phase, consisting of water, methanol and formic acid (55:45:0.5, v/v/v), at a flow-rate of 0.3mL/min. The transition monitored (positive mode) was m/z 279.1-->m/z 208.1 for triprolidine, m/z 165.9-->m/z 148.0 for pseudoephedrine and m/z 172.0-->m/z 154.0 for gabapentin (IS). This method had a chromatographic run time of 5.0min and a linear calibration curves ranged from 0.2 to 20.0ng/mL for triprolidine and 5.0-500.0ng/mL for pseudoephedrine. The within- and between-batch accuracy and precision (expressed as coefficient of variation, %C.V.) evaluated at four quality control levels were within 94.3-106.3% and 1.0-9.6% respectively. The mean recoveries of triprolidine, pseudoephedrine and gabapentin were 93.6, 76.3 and 82.0% respectively. Stability of triprolidine and pseudoephedrine was assessed under different storage conditions. The validated method was successfully employed for the bioequivalence study of triprolidine and pseudoephedrine formulation in twenty six volunteers under fasting conditions.

To evaluate the variation in prescribing by primary care doctors during the morning and the evening clinics and to determine whether these prescribing patterns are influenced by doctors' training background.A retrospective prescription-based study was carried out in 17 out of 20 primary care health centres in Bahrain distributed across the Kingdom.A total of 4472 prescriptions containing 10 588 drug-items covering the prescribing practice of approximately 90% primary care doctors were analysed. Paracetamol was the most commonly prescribed drug in both clinics. Drugs such as diclofenac sodium, amoxycillin, ibuprofen, chlorpheniramine, hyoscine butylbromide, Actifed, Benylin and xylometazoline were the most commonly prescribed drugs to patients attending morning and evening clinics with a considerable variation in ordinal ranking of proportions. As regards morning clinic, chlorpheniramine and Fefol were prescribed by the family doctors (FDs) more often than by the general practitioners (GPs) (P<0.05), whereas, multivitamins were prescribed by the GPs more often than by the FDs (P=0.001). During the evening clinic, however, ibuprofen, chlorpheniramine, bromhexine and xylometazoline were prescribed by the FDs in a rate significantly higher than that prescribed by the GPs (P<0.05). The prevalence of acute and/or chronic morbidities in patient attending clinics was estimated based on the therapeutic indication for drugs used. The mean number of drugs per prescription was 2.41+/-1.3. Prescriptions containing three or more drugs comprised 41.7% of all prescriptions. The GPs had a greater tendency to practice polypharmacy than the FDs.A significant diurnal variation in prescribing, and polypharmacy practice were related to the training background of the doctors. This quantitative study provides the baseline data for monitoring primary care prescribing practices in Bahrain. To further evaluate the underlying factors that influence drug use indicators, a qualitative study is needed.

Common colds are usually treated by the patients themselves with over-the-counter (OTC) cold medications. Many cough and cold remedies are available and sold freely without prescription. The authors conducted a study to compare the efficacy, adverse effects, the quality of life (QOL) and the patient's opinion and appreciation on the drugs (POD) between Dayquil/Nyquil and Actifed DM plus paracetamol syrup.In this prospective, investigator-blinded clinical trial, 120 patients, aged between 15 and 60 years old, with common colds within 72 hours, who accepted the trial and gave informed written consent, were randomized into two treatment groups. One patient was excluded due to evidence of bacterial infection. Fifty-nine patients were treated with Dayquil/Nyquil (D/N group), while the other 60 patients had Actifed DM plus paracetamol (ADM/P group) for three days. On day 1 the patient's demographic data (sex, age, body weight, blood pressure, co-existing diseases/conditions, drug use, and allergy to any drugs), the most prominent symptoms and its duration were recorded. All patients were screened for bacterial infection by physical examination, complete blood count and sinus radiographs. The symptoms (nasal obstruction, rhinorrhea, sneezing, cough, sore throat, fever and headache) and signs (injected nasal mucosa, nasal discharge and pharyngeal discharge) were scored, based on 4-point scale (0 to 3), on days 1 and 4. Changing of the symptoms and QOL were recorded on the diary card. The patient's opinion and appreciation on the drugs (POD) was assessed on day 4. The effectiveness (the ability to lessen the symptoms and signs), QOL and POD between two treatments were compared.The demographic data between the two groups were similar. The four most common prominent symptoms of common colds in our series were cough (47.9%), sore throat (26.17%), rhinorrhea (8.4%) and headache (8.4%). However, both treatments were equally effective in lessening the symptoms (P = 0.426) and signs (P = 0.716) of common cold from days 1 to 4. The adverse effects were significantly higher in ADM/P group than in D/N group (p = 0.006). In contrast, QOL in terms of alertness, freshness and sound sleep improved from day 1 to day 3 in both treatments, but the overall day-3 score was significantly higher in the D/N group than the ADM/P group (1.85 +/- 1.83; 1.25 +/- 1.94: p = 0.024). POD in terms of convenience, flavour of drug, effectiveness of the drug and a need to repeat the drug assessed on day 4, was also significantly higher in the D/N group than the ADM/P group (10.68 +/- 2.56; 8.92 +/- 2.27: p < 0.001).Dayquil/Nyquil are as effective as Actifed DM plus paracetamol in controlling the symptoms and signs of the common cold, but have fewer adverse effects. The quality of life assessed during the use of the drugs was significantly higher in the Dayquil/Nyquil group, and according to the patients, they prefered Dayquil/Nyquil more than Actifed DM plus paracetamol.

A kinetic method for the accurate and sensitive determination of triprolidine has been described. The method is based on the alkaline oxidation of triprolidine with KMnO(4). At a fixed time of 20 min, the formed manganate ion is spectrophotometrically measured at 612 nm. The concentration of triprolidine is calculated using the calibration equation for the fixed time method. Beer's law was obeyed from 6 to 40 microg ml(-1) and the R.S.D. (n=10) was 0.97%. Recovery was 99.80%. The method is suitable for quantitative determination of triprolidine in the presence of co-formulated drugs, since pseudoephedrine hydrochloride, which is frequently co-formulated with triprolidine did not interfere with this assay. The intra- and inter-day R.S.D. values indicated the ruggedness of the method. The method has been applied successfully to commercial tablet dosage form. The results obtained agreed with those obtained by the BP method. The determination of triprolidine by the fixed-concentration and rate constant methods is feasible with the calibration equations obtained, but the fixed time method proves to be more applicable.

In order to assess the efficacy of Rinasek in symptomatic treatment of seasonal and nonseasonal rhinitis, 40 ambulatory otorhinolaryngologic patients were multicentrically examined in a placebo controlled double-blind study. Clinical and other findings show that the drug worked excellent in 46.6%, well in 13.3%, weak in 13.3% and in 10% of patients it had no effects. Consequently, Rinasek worked positively in 73.2%, and that is the best reason to recommend its application.

A capillary gas chromatographic method with nitrogen specific detection is presented for measuring pseudoephedrine and its major metabolite norpseudoephedrine in urine after derivatization with trifluoroacetic anhydride. After the oral intake of 49.2 mg pseudoephedrine (ACTIFED) the active substance is nearly quantitatively excreted in urine over a 48 hr period. From 1 to 7 percent is metabolized to norpseudoephedrine. The intake of acetazolamide results in a suppression of the pseudoephedrine concentration for at least 12 h. The diuretic effect after the intake of 1.51 mineral water could be compared with the effect obtained with 1 mg bumetanide and results in a decrease in pseudoephedrine concentration by a factor 4 for several hours.

To obtain information on the use of prescribed and non-prescribed drugs in the general population of children 1590 children were surveyed in 1984-5 by weekly questionnaires filled out by parents. Drugs were taken in 13% of the 26 weeks studied and on 9% of the 182 days. Use in the summer and winter was similar. More than half (56%) of all drugs were taken on Saturdays and Sundays. Boys took drugs on 11% of days and girls on 8% of days. Almost half (45%) of drugs taken were not prescribed. Drugs acting on the respiratory tract and on coughs accounted for 42.2% of the drugs used. Analgesics were taken on 14.0% of days and antimicrobials on 12.5%. Aspirin accounted for 14.9% of all drugs used in any one week and for 31.7% of drugs obtained without prescription. Aspirin, paracetamol, triprolidine-pseudoephedrine (Actifed), ampicillin or amoxycillin, and salbutamol were the drugs most frequently used. The widespread use of drugs obtained without prescription suggests that community pharmacists and parents would benefit from further education on the choice of treatment in relation to symptoms. Doctors should be aware of the extent of treatment with non-prescription drugs and consider playing a greater part in advising on its indications.

Difference spectrophotometric procedures are described for the assay of triprolidine hydrochloride, dextromethorphan hydrobromide and pseudoephedrine hydrochloride in Actifed preparations. Triprolidine is assayed by the measurement of the difference absorbance at 301 nm between equimolar solutions of the sample extract in 0.1 M sulphuric acid and 0.1 M sodium hydroxide in ethanol (20% v/v). Dextromethorphan and pseudoephedrine are assayed by measurement of the amplitudes in the second and fourth derivative spectra of the difference absorption spectrum of the sample solutions. The measured values are proportional to the concentrations of the drugs. The accuracy, precision and selectivity of the procedures are discussed. Applications of the assay are described for Actifed Compound Linctus, Actifed Syrup and Actifed Tablets.