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The bioavailability of a single dose of ciprofloxacin 1000 mg Extended release (XR) tablets manufactured by a Jordanian manufacturer (Hikma PLC), was compared with a reference ciprofloxacin 1000 mg XR tablets (Cipro® XR, Bayer-health care, Germany) in two different studies (under fasting and fed conditions). In each study, 28 healthy, male, Jordanian volunteers were enrolled. However, only 25 subjects in fasting study and 23 subjects in fed study completed the crossover. Each study was designed as single-center, open-label, randomized, singledose, two-way crossover study. Nineteen blood samples were taken during 24hrs. Samples were frozen and kept until time of analysis. Ciprofloxacin concentrations in subjects' plasma were determined by using a validated HPLC fluorescence technique. Confidence intervals (90%) for the peak plasma concentration (C max ) and area under the concentration-time curve (AUC0-t) were determined by calculating log-transformed Test/Reference ratio using standard non-compartmental method and ANOVA statistics. The 90% CI result in fasting study for C max was 88.87 (82.17 -96.10)% and for AUC0-t was 87.60 (80.38-95.46)%. In fed study the results were 102. 09 (92.77-112.34)% and 104.06 (100.01-108.27)% for Cmax and AUC0-t, respectively. In conclusion, it is evident that the 90% CI for the primary pharmacokinetics parameters was within the bioequivalence acceptable boundaries of 80-125%, while for AUC0-t, and 75.-133% for C max . Therefore, it was concluded that both products were bioequivalent.

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Drug excipient compatibility studies are considered important in successful formulation of drug products. Suggested methods for this purpose are thermal techniques under isothermal or nonisothermal conditions. In this study, modafinil, a wakefulness-promoting drug, was investigated under nonisothermal conditions using differential scanning calorimetry. Four different heating rates, 5, 10, 15, and 20°C/min, were performed for modafinil pure material and its physical mixtures with magnesium stearate (MgSt) or Gelucire 48/16. Activation energy (Ea) was calculated from the straight line of plotting a function of heating rate versus temperature and found that modafinil-Gelucire physical mixture increased Ea. This indicates drug-excipient interaction, supported by evidence from Fourier transform infrared spectroscopy and nuclear magnetic resonance spectroscopy. No significant interaction was detected with MgSt.

The objective of this work was to study drug-excipient interactions in solid dosage forms when coated with dry powder film-coat compared with conventional aqueous film. Free films of Eudragit RL, (ERL) with or without drugs (Metoprolol Succinate or Diclofenac sodium) were prepared by casting method and characterized by FTIR, NMR, or DSC. Tablets of either drugs were prepared by wet granulation and coated in a fluidized-bed by ERL aqueous dispersion or micronized powder. Dissolution behavior and color change study were carried out for tablet batches on zero time and after 3 months of storage in stability chambers. The results of free films showed a greater possibility of drug polymer interaction in the aqueous dispersion than dry powder films. The results of dissolution rate revealed a greater rate change in aqueous-than in dry-coated tablets. This was confirmed by the Color change study which showed more intense yellowing in aqueous-coated tablets.