Drug Development and Industrial Pharmacy (DRUG DEV IND PHARM )

Publisher: Taylor & Francis


Covering aspects of the development, production, and evaluation of drugs and pharmaceutical products, this international journal highlights both the technical and regulatory facets of industrial pharmacy. Topics addressed within this continually evolving discipline include computerization of production, quality control, export problems, pharmacokinetics and biopharmaceutics, drug regulatory affairs, and successful manufacturing practices.

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Publications in this journal

  • [show abstract] [hide abstract]
    ABSTRACT: Abstract The inclusion complex formation between oxazepam (Ox) and heptakis (2,6-di-O-methyl)-β-cyclodextrin (DIMEB) was studied in solution by solubility and ultraviolet spectroscopy methods, and in the solid state by differential scanning calorimetry, scanning electron microscopy, and powder x-ray diffractometry. The apparent stability constant, Kc, calculated by solubility and spectral data, was estimated as 642 and 588 M-1, respectively. The solid complexes have been prepared by kneading and spray-drying techniques. The dissolution rate studies reveal that the better dissolution behavior corresponded to the spray-dried systems.
    Drug Development and Industrial Pharmacy 10/2008; 23(4):379-385.
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    ABSTRACT: Coprecipitates of morphine were prepared by using EudragitR L30D as a carrier in order to obtain controlled release dosage systems. Differential Scanning Calorimetry and IR, 1H- and 13C-NMR spectroscopies were applied in order to explain the mechanism of this interaction. The results obtained indicated that there was an intermolecular association between the polymer and the drug consisting in two different hydrogen bonds interactions. The proposed reaction involves coprecipitates having morphine contents greater than 50%.
    Drug Development and Industrial Pharmacy 10/2008; 20(15):2409-2424.
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    ABSTRACT: Abstract A novel analysis of drug release process from binary matrix systems has been realized and a study of the initial stage of the process has been carried out. A fast and easy technique has allowed the acquisition of one experimental datum per second. Release data have been analyzed by means of a detailed statistical study. The dissolution profiles were studied applying different kinetic models (zero order, logarithmic, and Higuchi equation). In all the cases studied, a starting process of zero or first order, indicative of a surface-dependent mechanism, has been found. Then, a parameter, named as critical time of kinetic change (tc), has enabled the authors to establish the instant at which a diffusion release mechanism, according to Higuchi equation, is consolidated. From this time until the end of the process, release mechanism of matrices was shown to be diffusion controlled. The influence of the drug loading and the particle size over the release properties of tablets has also been investigated and it has been evaluated on the basis of percolation theory. The results show a major significance of particle size over the initial drug release and a decrease of its influence along the time. On the other hand, the drug loading variable shows an important influence over the release properties along the whole process.
    Drug Development and Industrial Pharmacy 10/2008; 22(3):201-210.
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    ABSTRACT: Abstract We present an examination of the problems and requirements of the various international standards relating to the production (manufacture and control) of noninjectable, solid penicillin products. We describe a system developed in the setting up of a production department in a penicillin plant, and its treatment for subsequent validation.
    Drug Development and Industrial Pharmacy 10/2008; 22(6):541-554.
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    ABSTRACT: Abstract The release process from a controlled-release oral system of morphine, prepared using Eudragit® L30D as a carrier, is considered as the result of the combination of two different processes, the final release mechanism being a pH-dependent process. The release mechanism and the influence of the pH value on the dissolution behavior of this morphine complex were studied. An immediate morphine release, without any lag time, is produced in the three dissolution media employed. Considering an initial step of 120 min, the maximum release rate is reached in the assay carried out at pH = 1; above 120 min, the maximum amount of drug released was reached at pH = 7.02.
    Drug Development and Industrial Pharmacy 10/2008; 23(6):553-559.
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    ABSTRACT: Abstract A high-performance liquid chromatographic (HPLC) assay has been developed for thimerosal and some of its degradation products: thiosalicylic and 2,2′-dithiosalicylic acids. Using this method, the influence of formulation factors as: isotonic agent, initial concentration, addition of tromethamine, pH and container material, over thimerosal stability was studied.
    Drug Development and Industrial Pharmacy 10/2008; 19(14):1673-1691.
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    ABSTRACT: Abstract Diazepam-polyethyleneglycol 6000 solid dispersions systems were prepared by melting and solvent methods. These dispersions were characterized using D.T.A., X-Ray diffraction and microscopy. The phase diagram has shown that this system is characterized as a simple eutectic mixture with a eutectic composition of 87% diazepam and 13% P.E.G. 6000. Solubility studies showed a linear increase in drug solubility with the increase of PE.G. 6000 concentration.
    Drug Development and Industrial Pharmacy 10/2008; 16(15):2283-2301.
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    ABSTRACT: This present study is a preliminary exploration of the affinity between a carboxylic model drug ibuprofen and aluminum hydroxide. Ibuprofen was comilled with aluminum hydroxide in different weight ratios in the solid state and was characterized by scanning electron microscopy (SEM), X-ray powder diffractometry (XRD), Fourier transform infrared spectroscopy (FTIR), and in vitro dissolution studies. XRD and SEM studies indicated complete interaction of ibuprofen with aluminum hydroxide and complete amorphization of aluminum hydroxide-ibuprofen complexed salt as well, on comilling with aluminum hydroxide at 1:2 ratio. FTIR data showed the disappearance of acid carbonyl peak with the appearance and the corresponding increase in absorbance of new signal at 1,682 cm(-1) in the 1:1 and 1:2 ibuprofen-aluminum hydroxide-comilled powder. The accompanied increase in the absorbance of carboxylate peak in the ibuprofen-aluminum hydroxide physical mixture, and 1:0.1, 1:0.5, 1:1, and 1:2 (IBA(pm), and IB(1)A(0.1), IB(1)A(0.5), IB(1)A(1), and IB(1)A(2), respectively) comilled powder indicated an acid-base reaction between ibuprofen and aluminum hydroxide. On storage at 40 degrees C and 75% relative humidity (RH) for 10 weeks, XRD study showed the absence of reversion to the crystalline state and FTIR data revealed continued increase of new signal at 1,682 cm(-1) relative to carboxylic acid peak and no reappearance of carboxylic acid peak. In vitro dissolution studies revealed that the percent release of ibuprofen from the aluminum hydroxide-comilled powder is in the following order: IB(1)A(2) < IB(1)A(1) < ibuprofen crystal < ibuprofen milled alone < IB(1)A(0.1) < IB(1)A(0.5). Aluminum metal cation might have interacted to form a complex through the carboxyl and carbonyl groups of ibuprofen. Improved dissolution of drug associated with IB(1)A(0.1) and IB(1)A(0.5) is because of the absence of a new signal at 1,682 cm(-1) and improved amorphization of the drug to some extent. Dissolution of drug affected in IB(1)A(2) and IB(1)A(1) may be because of the insoluble stable complex formation.
    Drug Development and Industrial Pharmacy 08/2008; 34(7):726-34.
  • Drug Development and Industrial Pharmacy 06/2008; 34(5):558.
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    ABSTRACT: Diclofenac-bismuth complexation was attempted by mixing diclofenac sodium (Na) and bismuth-subcitrate aqueous solutions at diclofenac:bismuth molar ratio of 3:1. A solid precipitate was obtained and isolated. The precipitate was characterized for stoichiometric ratio of diclofenac-bismuth complexation using capillary electrophoresis, which showed 1:1 complexation. In addition, nuclear magnetic resonance and Fourier transform infrared analysis were performed for the isolated solid complex and indicated that bismuth was in coordinate bond formation with the carboxylate group of diclofenac. In comparison with diclofenac Na powder, the complex was evaluated as an aqueous suspension for in vitro drug dissolution. The complex exhibited a faster dissolution rate than and similar dissolution extent as diclofenac Na. In comparison with an aqueous solution of diclofenac Na and an aqueous suspension of physical mixture of diclofenac acid (suspended) and bismuth-subcitrate (dissolved), the aqueous complex suspension was evaluated for ulcerogenic effect in rats upon oral administration. The complex led to more gastric ulceration than diclofenac Na, which was not in accordance with the antiulcer properties of bismuth. This antiulcer effect was shown as the physical mixture administration was accompanied with lower gastric ulceration than diclofenac Na administration. These gastric ulceration results were explained in terms of the difference in particle size between solid diclofenac acid formed as a result of the complex breakdown in an acidic medium (0.1 M HCl to simulate the gastric fluid) and that formed as a result of diclofenac Na neutralization. Diclofenac acid particles formed from the complex breakdown were of average size, three times smaller of those formed as a result of diclofenac Na protonation. This difference in particle size was correlated with the higher gastric ulceration associated with the complex than with diclofenac Na in terms of higher coverage of the gastric mucosa with diclofenac, and consequently, higher local ulceration.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):434-44.
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    ABSTRACT: Topotecan-entrapping liposomes were prepared by freeze drying double emulsions with hydrogenated soy phosphatidylcholine, N-(carbonyl-methoxypolyethyleneglycol2000)-1,2-distearoyl-sn-glycero-3-phosphoethanolamine, and cholesterol. Different inner aqueous phases of different pH values containing topotecan together with different chemicals, such as citrate and sulfate, were used to modify the physicochemical state of the drug to prepare W1/O/W2 double emulsions that were then freeze dried to obtain dry products. Upon rehydration, the dry products, which were stable for at least 6 months, formed into unilamellar liposomes with a high encapsulation efficiency of up to 80% and a mean diameter below 200 nm. The in vitro release experiments demonstrated that different formulations displayed different drug release properties. Thus, stable submicron unilamellar topotecan-entrapping liposomes can be prepared by freeze drying double emulsions, and the drug release can be successfully controlled by altering the physicochemical state of the incorporated drug.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):427-33.
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    ABSTRACT: The objective of this study was to obtain detailed information on the mechanism of drug release from mixed-film of pectin-chitosan/Eudragit RS. Pellets (710-840 microm in diameter) containing 60% theophylline and 40% microcrystalline cellulose were prepared by extrusion-spheronization method. Eudragit L100-55 enteric coating capsules included film-coated pellets of theophylline in theoretical coating weight gains of 10, 15, and 20%, with pectin-chitosan complex contents of 5, 10, 15, and 20% for each level of weight gain were prepared and subjected to in vitro drug release. Drug release from this system showed a bimodal release profile characteristic with the drug release enhancement, being triggered (burst release) in the colonic medium. The reason for burst drug release may be due to the enzymatic degradation of pectin via pectinolytic enzymes in the simulated colonic medium. The mechanism of drug release from each formulation was evaluated in the terms of zero-order, first-order, Higuchi and Korsmeyer-Peppas models. It was observed that none of the enteric coating capsules showed any drug release in the simulated gastric medium (phase I). The analysis of release profiles showed that zero-order kinetics was found as the better fitting model for all formulations in the simulated small intestine (phase II) and it could be due to the pectin-chitosan swelling and subsequent formation of aqueous channels. In the colonic medium (phase III), due to degradation of pectin and its leaching from the mixed-film, there was a modification in drug release kinetics from swelling-controlled at phase II to anomalous at phase III. It also was found that both zero-order and Higuchi models contributed in colonic drug release from most of the formulations.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):390-402.
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    ABSTRACT: Gastric emptying is a complex process that is highly variable and makes the in vivo performance of drug delivery systems uncertain. In order to avoid this variability, efforts have been made to increase the retention time of the drug delivery systems for more than 12 hours utilizing floating or hydrodynamically controlled drug delivery systems. The objective of this investigation was to develop a floating, depot-forming drug delivery system for an antidiabetic drug based on microparticulate technology to maintain constant plasma drug concentrations over a prolonged period of time for effective control of blood sugar levels. Formulations were optimized using cellulose acetate as the polymer and evaluated in vitro for physicochemical characteristics and drug release in phosphate buffered saline (pH 7.4), and evaluated in vivo in healthy male albino mice. The shape and the surface morphology of the prepared microspheres were characterized by optical microscopy and scanning electron microscopy. In vitro drug release studies were performed and drug release kinetics were calculated using the linear regression method. Effects of stirring rate during preparation and polymer concentration on the size of microspheres and drug release were observed. The prepared microspheres exhibited prolonged drug release (more than 10 hours) and remained buoyant for over 10 hours. Spherical and smooth-surfaced microspheres with encapsulation efficiency ranging from 73% to 98% were obtained. The release rate decreased and the mean particle size increased at higher polymer concentrations. Stirring speed affected the morphology of the microspheres. This investigation revealed that upon administration, the biocompatible depot-forming polymeric microspheres controlled the drug release and plasma sugar levels more efficiently than plain orally given drug. These formulations, with their reduced frequency of administration and better control over drug disposition, may provide an economic benefit to the user compared with products currently available for diabetes control.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):349-54.
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    ABSTRACT: We have encapsulated indomethacin into poly (lactide-co-glycolide) (PLGA) using coaxial ultrasonic atomization technique. The specific aims of this study were to evaluate the effect of drug loading and a change in relative concentration of polymer in the inner and outer layers of coflowing spray liquids on the physicochemical characteristics of the particles. Indomethacin, a non steroidal anti-inflammatory drug, was selected as a model compound. The micro/nanocapsules prepared using a drug free PLGA solution as an outer layer showed higher encapsulation efficiency. Thermal analysis of the formulations indicated that indomethacin was dissolved within the PLGA matrix. The formulations prepared with 25 mg indomethacin showed relatively smaller particle size compared with the formulations prepared with 50 mg indomethacin. The particles, in general, showed bi- and tri-modal distribution. Irrespective of the compositions of the liquids 1 and 2, all the particles were smooth and spherical. A cross-section view of the particles revealed the presence of three different internal morphologies. These formulations were a mixture of hollow or solid spheres, and single or multiple spheres encapsulated into a larger sphere. To the best of our knowledge, this is the first study revealing the cross-sectional view of particles prepared with coaxial ultrasonic atomization technique.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):419-26.
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    ABSTRACT: This article focuses on preparation and evaluation of a once a day ophthalmic delivery system for ciprofloxacin hydrochloride based on the concept of pH-triggered in situ gelation. The in situ gelling system involves the use of polyacrylic acid (Carbopol 980NF) as a phase transition polymer, hydroxypropyl methylcellulose (Methocel K100LV) as a release retardant, and ion exchange resin as a complexing agent. Ciprofloxacin hydrochloride was complexed with ion exchange resin to avoid incompatibility between drug and polyacrylic acid. The developed formulation was stable, and nonirritant to rabbit eyes and in vitro drug release was found to be around 98% over a period of 24 hours.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):445-52.
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    ABSTRACT: The aim of this study was to develop nanostructured lipid carriers (NLC) for transdermal delivery of Flurbiprofen (FP). The physical stability of FP-NLC and its in vitro permeation profile were investigated. After three months of storage at 4 degrees C, 20 degrees C, and 40 degrees C, no significant differences between the evaluated parameters, such as pH value, the entrapment efficiency, particle size, and zeta potential were observed. In in vitro permeation studies, the cumulative permeated amounts and the release rate from FP-NLC were 412.53 +/- 21.37 microg/cm(2) and 35.25 microg/cm(2)/h after 12 h (n = 6), respectively, while from saturated FP-PBS (pH = 7.4) were 90.83 +/- 8.67 microg/cm(2) and 6.99 microg/cm(2)/h, respectively. These results indicated that the FP-NLC were with good physical stability and were able to improve the permeated amounts and the release rate of FP. It could potentially be exploited as a carrier with improved drug entrapment efficiency and permeated amount in the transdermal delivery of FP.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):453-8.
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    ABSTRACT: The aim of this work was to optimize time-dependent tablets using artificial neural network (ANN). The time-dependent tablet consisted of a tablet core, which contained sustained release pellets (70% isosorbide-5-mononitrate [5-ISMN]), immediate release granules (30% 5-ISMN), superdisintegrating agent (sodium carboxymethylstarch, CMS-Na), and other excipients, surrounded by a coating layer composed of a water-insoluble ethylcellulose and a water-soluble channeling agent. The chosen independent variables, i.e., X(1) coating level of tablets, X(2) coating level of pellets, and X(3) CMS-Na level, were optimized with a three-factor, three-level Box-Behnken design. Data were analyzed for modeling and optimizing the release profile using ANN. Response surface plots were used to relate the dependent and the independent variables. The optimized values for the factors X(1)-X(3) were 4.1, 14.1, and 29.8%, respectively. Optimized formulations were prepared according to the factor combinations dictated by ANN. In each case, the observed drug release data of the optimized formulations were close to the predicted release pattern. An in vitro model for predicting the effect of food on release behavior of optimized products was used in this study. It was concluded that neural network technique could be particularly suitable in the pharmaceutical technology of time-dependent dosage forms where systems were complex and nonlinear relationships often existed between the independent and the dependent variables.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):363-72.
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    ABSTRACT: Antimicrobial efficacy of methyl and propylparaben combination as potential preservatives for submicron emulsions, and the effect of oil and lecithin concentration on the microbial growth were investigated. Parabens were ineffective in standard or doubled concentrations as per pharmacopoeial criteria. Poor growth inhibition and multiplication of reference strains point to protective and growth properties of submicron emulsions. No correlation was observed between oil/lecithin ratio and efficacy of parabens; partitioning of the latter into the oily phase and lipophilic domains could be the reason for such effect. Further studies are necessary to establish a stable and safe composition of such formulations.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):355-62.
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    ABSTRACT: Enhanced systemic absorption in vivo and percutaneous penetration in vitro was demonstrated after transdermal administration of diclofenac sodium formulated in U-type microemulsion. Diclofenac sodium was solubilized in a typical four-component system consisting of an oil, polyoxyethylene-10EO-oleyl alcohol (Brij 96V) as the surfactant, and 1-hexanol along water dilution line W46 (40 wt % surfactant and 60 wt % oil phase before water titration). Viscosity and small angle X-ray scattering measurements have evidenced bicontinuous structures within water fractions of 0.25 and 0.5 along the dilution line. Self-diffusion NMR studies showed that drug molecules accumulated in the interfacial film and, to some extent, dissolved in the oil. Relative to a commercial macro-emulsion cream (Voltaren Emulgel), microemulsions containing paraffin oil or isopropyl myristate increased the in vivo transdermal penetration rate of diclofenac by two order of magnitude, whereas the rat plasma levels were increased by one order of magnitude. The in vitro data obtained from excised rat skin were comparable to the in vivo results, but suffered from discrepancies from the ideal in vivo-in vitro correlation, which might be explained by optimal in vitro conditions of perfusion and hydration. It has also been found that when jojoba oil is formulated as the oil phase in the microemulsion, the penetration rate of the drug decreases significantly. Based on the three-dimensional structure of jojoba oil, the wax is presumed to prevent the drug from being freely diffused into the skin while migrating from the interfacial film into the continuous oil phase.
    Drug Development and Industrial Pharmacy 05/2008; 34(4):403-12.

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