Stability of extemporaneous erlotinib, lapatinib, and imatinib oral suspensions.

PURPOSE: The stability of extemporaneously prepared erlotinib, lapatinib, and imatinib oral liquid dosage forms using two commercially available vehicles when stored at 4 and 25 °C was evaluated. METHODS: Three batches of extemporaneous oral suspensions were prepared for each drug. Erlotinib and lapatinib tablets were crushed and mixed in a 1:1 mixture of Ora-Plus:Ora-Sweet solution to yield 10- and 50-mg/mL suspensions, respectively. Imatinib tablets were crushed and mixed in Ora-Sweet solution to yield a 40-mg/mL suspension. Suspensions were stored in amber plastic bottles, and samples from each bottle were obtained on days 0, 1, 3, 7, 14, and 28. RESULTS: Erlotinib 10-mg/mL and lapatinib 50-mg/mL oral suspensions in a 1:1 mixture of Ora-Plus and Ora-Sweet retained at least 90% of their initial concentration throughout the 28-day study when stored at 25 °C. Visual inspection revealed notable viscosity changes in the erlotinib and lapatinib suspensions stored at 4 °C for 7 days and beyond. The viscosity of these preparations increased with time and was particularly evident with the erlotinib suspension, which exhibited a puddinglike texture. Imatinib 40-mg/mL oral suspension in Ora-Sweet appeared stable for up to 14 days when stored at both 25 and 4 °C. CONCLUSION: Erlotinib 10-mg/mL and lapatinib 50-mg/mL oral suspensions prepared from commercially available tablets were stable for at least 28 days when prepared in a 1:1 mixture of Ora-Plus:Ora-Sweet at 25 °C. Imatinib 40-mg/mL oral suspension prepared from commercially available tablets was stable for up to 14 days when prepared in Ora-Sweet and stored at 25 and 4 °C.

Development and validation of a reversed-phase HPLC method for monitoring of synthetic reactions during the manufacture of a key intermediate of an anti-hypertensive drug.

A reversed-phase high-performance liquid-chromatographic method for monitoring of reactions involved in process development of a key intermediate of antihypertensive drugs, e.g, doxazosin mesylate, prazosin, alfuzosin, terazosin, etc., has been developed and validated. The HPLC profiles of impurities of 4-amino-2-chloro-6,7-dimethoxyquinazoline were used as fingerprints to follow the synthetic procedures in the manufacturing unit. The separation was accomplished on an Inertsil ODS-3 column with isocratic elution using acetonitrile-ammonium acetate (10 mM; pH 4.0; 50:50 v/v) as mobile phase and a photodiode array detector set at 240 nm at ambient temperature. The method was validated with respect to accuracy, precision, linearity, and limits of detection and quantification. The method could detect the impurities at a level of 0.01 to 0.20 microg/mL and it was found to be suitable not only for monitoring of reactions but also for quality assurance of 4-amino-2-chloro-6,7-dimethoxyquinazoline.

Anticoccidial efficacy of toltrazuril and halofuginone against Eimeria tenella infection in broiler chickens in Egypt.

The anticoccidial activities of toltrazuril and halofuginone against Eimeria tenella were tested in broiler chickens. Comparisons were made between ummedicated infected and uninfected control birds in addition to infected groups given either toltrazuril at 37.5, 75 and 150 ppm in the drinking water, or halofuginone at 1.5, 3 and 6 ppm in the feed. Both drugs were highly efficacious against E tenella. Treatment improved the bodyweight gain and survival percentage in comparison with the unmedicated, infected group. Intestinal lesions, faecal and oocyst scores and oocyst shedding in dropping were significantly reduced by both drugs. Toltrazuril gave better protection than halofuginone; 75 and 150 ppm toltrazuril in drinking water gave good protection when administered four and five days after inoculation.

[Studies on the identification of psychotropic substances. IX. Preparation and various analytical data of reference standard of new psychotropic substances, N-ethyl methylenedioxyamphetamine, N-hydroxy methylenedioxyamphetamine, mecloqualone, 4-methylaminorex, phendimetrazine and phenmetrazine].

The reference standards of N-Ethyl methylenedioxyamphetamine, N-Hydroxy methylenedioxy-amphetamine, Mecloqualone, 4-Methylaminorex. Phendimetrazine and Phenmetrazine were chemically prepared from commercial chemicals. Their purities determined by HPLC were more than 99.8%. The standard spectra and chromatograms of the standards such as TLC, UV, IR, HPLC, GC/MS and NMR were measured. For the identification of these six drugs in forensic laboratory, their mass fragmentation and NMR spectra were discussed.