Development and validation of a method for quantitative determination of econazole nitrate in cream formulation by capillary zone electrophoresis

A simple, fast, inexpensive and reliable capillary zone electrophoresis (CZE) method for the determination of econazole nitrate in cream formulations has been developed and validated. Optimum conditions comprised a pH 2.5 phosphate buffer at 20 mmol L(-1) concentration, +30 kV applied voltage in a 31.5 cm x 50 mu m I.D. capillary. Direct UV detection at 200 nm led to an adequate sensitivity without interference from sample excipients. A single extraction step of the cream sample in hydrochloric acid was performed prior to injection. Imidazole (100 mu g mL(-1)) was used as internal standard. Econazole nitrate migrates in approximately 1.2 min. The analytical curve presented a coefficient of correlation of 0.9995. Detection and quantitation limits were 1.85 and 5.62 mu g mL(-1), respectively. Excellent accuracy and precision were obtained. Recoveries varied from 98.1 to 102.5% and intra- and inter-day precisions, calculated as relative standard deviation (RSD), were better than 2.0%. The proposed CZE method presented advantageous performance characteristics and it can be considered suitable for the quality control of econazole nitrate cream formulations. (c) 2008 Elsevier B.V. All rights reserved.

Development of a Bacillus sphaericus tablet formulation and its evaluation as a larvicide in the biological control of Culex quinquefasciatus

This study aimed to analyze the final fermentation culture of Bacillus sphaericus 2362, standardize it and develop an active tablet formulation for use in urban mosquito breeding sites. It was performed in three phases: analysis and standardization of a B. sphaericus fermented culture; physical, chemical, and biological analysis of the active powder (solubility, residual humidity, particle size, resting angle, flowing off time, compacted density, and biological activity against Culex quinquefasciatus larvae); and the development of fast-disintegrating tablets. Five formulations with differing compositions were developed and a UV protector was added to the selected formulation. The formulation products with or without UV protector, as well as the active powder caused 100% larval mortality from 1 day to 2 months after a single treatment under simulated field conditions. These results show that the UV protector does not affect the initial larvicide activity of B. sphaericus, nor its persistence over a period of two months.

Customer expectation study in product development process and its role in strategy formulation

Tämä työ on tehty kansainväliselle metsäteollisuusyritykselle. Työn lähtökohtana oli tarve tutkia yrityksen mahdollisuuksia laajentaa toimintaansa uudelle markkinasegmentille, eläinruokapakkausmarkkinoille. Johtuen maailmanlaajuisesta eläinruoankulutuksen kasvusta, eläinruokapakkaukset ovat yritykselle mielenkiintoinen uusi markkina-alue. Onnistunut markkinoilletulo vaatii asiakastarpeiden ja -odotusten huomioimista tuotekehitys- ja markkinastrategian muodostamisessa. Tämän työn tavoitteena oli selvittää asiakkaiden odotuksia eläinruokapakkauksille, sekä mallintaa alalla vallitsevia ostoprosesseja. Asiakastarvetutkimus suunniteltiin perustuen kirjallisuuteen ja alustaviin markkina- ja asiakasanalyyseihin. Alustavat analyysit ovat tarpeellisia lähtötilanteen ja trendien selvittämiseksi. Itse tutkimus toteutettiin semi-konstruktoituna teemahaastatteluna. Haastateltavat edustivat USA:n ja Euroopan johtavia eläinruokavalmistajia ja pakkausten jatkojalostajia. Työn tuloksena saatiin yksityiskohtaista tietoa asiakkaiden odotuksista eläinruokapakkauksille, paperin ominaisuuksille ja paperitoimittajille. Lisäksi mallinnettiin ostoprosesseja paperitoimittajien, pakkausten jalostajien ja eläinruokavalmistajien välillä. Tulosten perusteella on analysoitu yrityksen mahdollisuuksia menestyä uudella markkinasegmentillä. Lisäksi työssä annettiin ehdotuksia tuotekehitys- ja markkinastrategian muodostamiseen.

Development of beam and plate finite elements based on the absolute nodal coordinate formulation

The focus of this dissertation is to develop finite elements based on the absolute nodal coordinate formulation. The absolute nodal coordinate formulation is a nonlinear finite element formulation, which is introduced for special requirements in the field of flexible multibody dynamics. In this formulation, a special definition for the rotation of elements is employed to ensure the formulation will not suffer from singularities due to large rotations. The absolute nodal coordinate formulation can be used for analyzing the dynamics of beam, plate and shell type structures. The improvements of the formulation are mainly concentrated towards the description of transverse shear deformation. Additionally, the formulation is verified by using conventional iso-parametric solid finite element and geometrically exact beam theory. Previous claims about especially high eigenfrequencies are studied by introducing beam elements based on the absolute nodal coordinate formulation in the framework of the large rotation vector approach. Additionally, the same high eigenfrequency problem is studied by using constraints for transverse deformation. It was determined that the improvements for shear deformation in the transverse direction lead to clear improvements in computational efficiency. This was especially true when comparative stress must be defined, for example when using elasto-plastic material. Furthermore, the developed plate element can be used to avoid certain numerical problems, such as shear and curvature lockings. In addition, it was shown that when compared to conventional solid elements, or elements based on nonlinear beam theory, elements based on the absolute nodal coordinate formulation do not lead to an especially stiff system for the equations of motion.

Development and validation of a LC-method for the determination of phenols in a pharmaceutical formulation containing extracts from Stryphnodendron adstringens

A sensitive RP-HPLC method with UV detection successfully measured phenol(s) in an ointment containing 3% Stryphnodendron adstringens extract. Chromatography used acetonitrile (0.05% trifluoroacetic acid):water (0.05% trifluoroacetic acid) (v/v), flow rate 0.8 mL min-1. Quantitation was accomplished by the external-standard method. Linearity for 2.00 to 16.00 μg mL-1 (gallic acid) and 1.14 to 18.24 μg mL-1 (gallocatechin) was established. Intra- and inter-day precision levels were under 5%. LOD and LOQ were 0.231 and 0.770 μg mL-1 (gallic acid) and 0.151 and 0.504 μg mL-1 (gallocatechin), respectively. Determination of phenols was unaffected by product excipients.

Development and validation of a novel stability indicating RP-UPLC method for simultaneous determination of nizatidine, methylparaben and propylparaben in oral liquid pharmaceutical formulation

A selective and accurate stability-indicating gradient reverse phase ultra performance liquid chromatographic method has been developed and validated for the simultaneous determination of nizatidine, methylparaben and propylparaben in pharmaceutical oral liquid formulation. The separation was achieved on Acquity UPLC TM HSS T3 1.8 µm column by using mobile phase containing a gradient mixture of solvent A (0.02 Mol L-1 KH2PO4, pH 7.5) and B (60:40 v/v mixture of methanol and acetonitrile) at flow rate of 0.4 mL min-1. Drug product was exposed to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The developed method was validated as per international ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.

Development of a topical formulation containing S. Lutea extract: Stability, in vitro studies and cutaneous permeation

Flavonoids have been widely incorporated into cosmetic and dermatological formulations, affording benefits such as antioxidant action, improved skin tone and fewer lines and wrinkles. Brazil has a huge biodiversity, with one of the richest flora in the world, and existing studies justify the quest for greater research efforts in this area. The cajazeira (Spondias lutea L.), a plant of the Anacardiaceae family from tropical America, is widely disseminated in Brazil. This plant was chosen because of the presence of flavonoids that exhibit antioxidant activity. The purpose of this research was to develop a stable topical formulation containing Spondias lutea extract with the aim of preventing skin diseases caused by UV radiation. Hydro ethanolic extract of Spondias lutea fruit was prepared and assayed for its the flavonoids content. The antioxidant activity was estimated by DPPH and superoxide assay. The physicochemical stability and skin permeation of the cream containing 8% (w/w) of extract were assessed. The results showed that the S. lutea extract possessed antioxidant activity, and that it is possible to obtain a stable cosmetic containing the extract, which is able to penetrate the skin. Thus, it is possible to use this extract to produce an anti-aging cosmetic.

Population policy formulation and integration of population in development planning in the Caribbean-Jamaica's experience

Includes bibliography

Joint development and value capture in Los Angeles : local policy formulation /

"DOT-I-83-23."

Ohio River Basin comprehensive survey-- [microform] main report and development program formulation. Communication from the Chairman, United States Water Resources Council, transmitting the Council's report on a comprehensive program for water and related land use in the Ohio River Basin, pursuant to Public law 89-80.

Reuse of record except for individual research requires license from Congressional Information Service, Inc.

The role of formulation excipients in the development of lyophilised fast-disintegrating tablets

Despite recent Success, many fast-disintegrating tablets (FDTs) still face problems of low mechanical strength, poor mouth-feel and higher disintegration times. This Study aimed to optimise FDTS using a progressive three-stage approach. A series of hardness, fracturability and disintegration time tests were performed on the formulations at each stage. During Stage 1, tablets were prepared in concentrations between 2% and 5% w/w, and were formulated at each concentration as single and combination bloom strength gelatin (BSG) using 75 and 225 BSGs. Analysis revealed that both hardness and disintegration time increased with an increase in gelatin concentration. A combination (5% gelatin) FDT comprising a 50:50 ratio of 75:225 BSGs (hardness: 13.7 +/- 0.9 N and disintegration time: 24.1 +/- 0.6 s) was judged the most ideal, and was carried forward to Stage II: the addition of the saccharides sorbitol, mannitol and sucrose in concentrations between 10% and 80% w/w. The best properties were exhibited by mannitol-containing formulations (50%-hardness: 30.9 +/- 2.8 N and disintegration time: 13.3 +/- 2.1 s), which were carried forward to the next stage: the addition of viscosity-modifying polymers to improve mouth-feel and aid pre-gastric retention. Addition of carbopol 974P-NF resulted in the enhancement of viscosity with a compromise of the hardness of the tablet, whereas Pluronic F127 (6%) showed an increase in disintegration time and viscosity with retention of mechanical propel-ties. (C) 2008 Elsevier B.V. All rights reserved.

Development and formulation of wax-based transdermal drug delivery systems

Topical and transdermal formulations are promising platforms for the delivery of drugs. A unit dose topical or transdermal drug delivery system that optimises the solubility of drugs within the vehicle provides a novel dosage form for efficacious delivery that also offers a simple manufacture technique is desirable. This study used Witepsol® H15 wax as a abase for the delivery system. One aspect of this project involved determination of the solubility of ibuprofen, flurbiprofen and naproxen in the was using microscopy, Higuchi release kinetics, HyperDSC and mathematical modelling techniques. Correlations between the results obtained via these techniques were noted with additional merits such as provision of valuable information on drug release kinetics and possible interactions between the drug and excipients. A second aspect of this project involved the incorporation of additional excipients: Tween 20 (T), Carbopol®971 (C) and menthol (M) to the wax formulation. On in vitro permeation through porcine skin, the preferred formulations were: ibuprofen (5% w/w) within Witepsol®H15 + 1% w/w T; flurbiprofen (10% w/w) within Witepsol®H15 + 1% w/w T; naproxen (5% w/w) within Witepsol®H15 + 1% w/w T + 1% C and sodium diclofenac (10% w/w) within Witepsol®H15 + 1% w/w T + 1% w/w T + 1% w/w C + 5% w/w M. Unit dose transdermal tablets containing ibuprofen and diclofenac were produced with improved flux compared to marketed products; Voltarol Emugel® demonstrated flux of 1.68x10-3 cm/h compared to 123 x 10-3 cm/h for the optimised product as detailed above; Ibugel Forte® demonstrated a permeation coefficient value of 7.65 x 10-3 cm/h compared to 8.69 x 10-3 cm/h for the optimised product as described above.

Formulation and development of cationic liposomes as adjuvants for subunit protein vaccinese

Liposomes remain at the forefront of vaccine design due to their well documented abilities to act as delivery vehicles and adjuvants. Liposomes have been described to initiate an antigen depot-effect, thereby increasing antigen exposure to circulating antigen-presenting cells. More recently, in-depth reviews have focussed on inherent immunostimulatory abilities of various cationic lipids, the use of which is consequently of interest in the development of subunit protein vaccines which when delivered without an adjuvant are poorly immunogenic. The importance of liposomes for the mediation of an antigen depot-effect was examined by use of a dual-radiolabelling technique thereby allowing simultaneous detection of liposomal and antigenic components and analysis of their pharmacokinetic profile. In addition to investigating the biodistribution of these formulations, their physicochemical properties were analysed and the ability of the various liposome formulations to elicit humoral and cell-mediated immune responses was investigated. Our results show a requirement of cationic charge and medium/strong levels of antigen adsorption to the cationic liposome in order for both a liposome and antigen depot-effect to occur at the injection site. The choice of injection route had little effect on the pharmacokinetics or immunogenicity observed. In vitro, cationic liposomes were more cytotoxic than neutral liposomes due to significantly enhanced levels of cell uptake. With regards to the role of bilayer fluidity, liposomes expressing more rigid bilayers displayed increased retention at the injection site although this did not necessarily result in increased antigen retention. Furthermore, liposome bilayer rigidity did not necessarily correlate with improved immunogenicity. In similar findings, liposome size did not appear to control liposome or antigen retention at the injection site. However, a strong liposome size correlation between splenocyte proliferation and production of IL-10 was noted; specifically immunisation with large liposomes lead to increased levels of splenocyte proliferation coupled with decreased IL-10 production.