Current approaches of nanomedicines in the market and various stage of clinical translation

Compared with traditional drug therapy, nanomedicines exhibit intriguing biological features to increase therapeutic efficiency, reduce toxicity and achieve targeting delivery. This review provides a snapshot of nanomedicines that have been currently launched or in the clinical trials, which manifests a diversified trend in carrier types, applied indications and mechanisms of action. From the perspective of indications, this article presents an overview of the applications of nanomedicines involving the prevention, diagnosis and treatment of various diseases, which include cancer, infections, blood disorders, cardiovascular diseases, immuno-associated diseases and nervous system diseases, etc. Moreover, the review provides some considerations and perspectives in the research and development of nanomedicines to facilitate their translations in clinic.

Toxigenic Profiling of Enterotoxin-Producing Bacillus cereus Isolated from Marketed Raw Chicken Meat and Human Subjects by Triplex and Multiplex PCR

Bacillus cereus incorporates the most important group of endospore-forming micro organism and can cause emetic and diarrheal food poisoning. A total of 42 B. cereus strains isolated from marketed raw chicken meat and human subjects swab samples were assessed by a triplex and multiplex PCR for the presence of enterotoxin genes. The detection rate of nheB, hblA, hblD, cytK, nheA,CER, hblC and entFM enterotoxin genes among all B. cereus strains was 83.33%, 80.95%, 69.04%, 21.42%, 47.61%, 0%, 61.90%, and 92.85% respectively. Enterotoxigenic profiles were determined in enterotoxin-producing strains showed 19 different patterns. The results offer essential information on toxin genes prevalence and toxigenic profiles of B. cereus from sources of origin. The present study was taken into consideration about extreme fitness danger for public health and insuring extra ability in difficulty to food safety amongst all B. cereus group members. Also, there may be need for extensive and continuous tracking of food products embracing both emetic toxin and enterotoxin genes.

Novel Hptlc-Densitometric Method For The Estimation Of Teriflunomide In Tablet Dosage Form

Objective: The current work is intended towards the development of a novel, simple and precise high-performance thin layer chromatographic (HPTLC) method coupled with a densitometer for the estimation of teriflunomide (TEF) present in the marketed formulation. Methods: The chromatographic development was performed on aluminum plates coated with silica gel 60 F254 using toluene: ethyl acetate: glacial acetic acid (7.5:2: 0.5 v/v/v) as the mobile phase. Densitometric scanning was achieved at the absorbance maxima, UV 284 nm. Results: Well separated band was observed with Rf value 0.46. The calibration curve plotted in the concentration range 100-700ng/band exhibited an excellent linear relationship with the r2 value of 0.9928. The method was found to comply with all the validation parameters as per the ICH guidelines. Conclusion: The method ensures minimal use of mobile phase with minimal run time compared to other reported analytical methods. This validated method can be used by quality control laboratories for the routine quantitative analysis of tablets consisting of Teriflunomide.

Investigação do teor de nitrito em amostras de mortadelas comercializadas em Luziânia-GO e Brasília-DF / Nitrite level assessment for bologna products commercialized in Luziânia-GO and Brasília-DF

Objetivo ­ Investigar a concentração de nitritos presentes em mortadelas produzidas e comercializadas para o público infantil, avaliando a adequação destas com legislação brasileira. Para tal, foram analisadas seis amostras de produtos adquiridas em diferentes pontos de venda: três em Luziânia (GO) e outro em Brasília (DF). Métodos ­ As amostras foram analisadas em triplicata, utilizando o método de Griess-Ilosvay. Todas as amostras analisadas apresentaram teores de nitrito dentro dos limites exigidos. Resultados ­ Contudo, é preciso considerar a possibilidade de combinação destes, com substâncias presentes na matriz alimentar e consequente formação de nitrosaminas, cujo elevado potencial mutagênico e carcinogênico são conhecidos. Conclusão ­ Sendo assim, o monitoramento do teor de nitrito, principalmente dessa categoria de alimentos, deve ser permanente no intuito de assegurar aos consumidores produtos seguros e de qualidade.

Objective ­ To investigate the concentration of nitrite present in bologna produced and marketed for children, assessing their adequacy to the Brazilian law. In order to proceed with this investigation, it has been analyzed six samples of products acquired in different groccery stores: three from Luziânia (GO) and one from Brasília (DF). Methods ­ The samples were analyzed in triplicate using the Griess-Ilosvay method. The results have shown that all samples were within the standards set by law. Results ­ However, it must be considered that nitrites can combine with some food matrix substances generating nitrosamines, which are known to have a high mutagenic and carcinogenic potential. Conclusion ­ Therefore, the level of nitrites, particularly in foods targeted for children, must be constantly monitored.

RP-HPLC and HPTLC Methods for Simultaneous Estimation of Metformin Hydrochloride and Vildagliptin from Bulk and Marketed Formulation: Development and Validation.

The reversed-phase high performance liquid chromatography (RP-HPLC) and high performance thin layer chromatography (HPTLC) methods for simultaneous estimation of Metfomin Hydrochloride (MET) and Vildagliptin (VLD) in bulk and their marketed combined dosage form were developed. For RP-HPLC, separation was carried out using HiQsil C18HS (4.6mmø×250mm) analytical column and detection was carried out using variable wavelength detector. The mobile phase was composed of phosphate buffer (pH adjusted to 6 using 3M KOH): methanol: acetonitrile in the ratio of 50:30:20 v/v/v. Flow rate was kept at 0.8ml/min. The drugs- MET and VLD were retained at 3.7 minutes and 4.8 minutes respectively. The HPTLC method was developed using Camag HPTLC system. Silica Gel 60GF254 precoated TLC plates were used as stationary phase. The mobile phase was ammonium acetate in methanol (1% w/v): Toluene; (10:0.5). The detection of spots was carried out densitometrically at 214 nm in absorbance mode. The Rf values for MET and VLD were found to be 0.44 and 0.55 respectively. Performance characteristics of both of these RP-HPLC and HPTLC methods for simultaneous estimation of MET and VLD in bulk and their marketed combined dosage form were statistically validated as per the recommendations of ICH guidelines of analytical method validation. The RP-HPLC method was found to be linear across concentration range of 10-60μg/mL for MET and VLD respectively. For RP-HPLC the LOD values for MET and VLD were 1.09μg/ml and 1.70μg/ml respectively and LOQ values for MET and VLD were 3.32μg/ml and 5.15μg/ml respectively. The HPTLC method was found to be linear with across the range 1000-5000ng/spot and 500-2000ng/spot for MET and VLD respectively. For HPTLC the LOD values for MET and VLD were 17.22ng/spot and 34.60ng/spot respectively and LOQ values for MET and VLD were 52.20ng/spot and 104.85ng/spot respectively. Both of these RP-HPLC and HPTLC methods were found to be simple, specific, linear, accurate, precise and robust, hence any of these methods can be conveniently adopted for routine analysis of the formulations containing MET and VLD, for their simultaneous estimation.

Self emulsifying drug delivery system: a promising approach for bioavailability enhancement.

About 40% of the drug candidates have poor water solubility due to their low bioavailability. Self-emulsifying drug delivery systems (SEDDs) are mixtures of oils, surfactants and co-surfactants, which efficiently improve dissolution and bioavalabilty of sparingly soluble drugs by rapid self-emulsification. SEDDs belongs to lipid formulations, and size ranges from 100nm (SEDDs) to less than 50nm (SMEDDs). Lipophilic drugs can be dissolved in such systems, enabling them to be administered as a unit dosage form for per-oral administration. When such system is released in the lumen of the gastrointestinal tract, it disperses to form a micro/nano emulsion with the aid of GI fluid. These leads to solubilisation of drug that can subsequently be absorbed by lymphatic pathways, by passing the hepatic first pass effect.

Per oral extended release products -An overview.

The use of extended-release products offers some potential advantages in patient convenience, compliance and therapeutic outcomes. However, the range of drugs for which clinically significant advantages have been shown is limited. Prescribers and pharmacists should be aware of these products and have knowledge of their clinical use in selected patient groups. In some instances, the formulation is probably serving a marketing objective rather than a clinical objective.

Validation and application of a modified RP-HPLC method for the quantification of midazolam in pharmaceutical dosage forms.

The purpose of the study was to develop a simple, sensitive and rapid RP-HPLC method for the determination of Midazolam in marketed products. Chromatographic determination was performed in a reverse phase C18 column (250 mm × 3.3 mm I.D. , 5μm particle size) using a mixture of acetonitrile: methanol: 0.065 M ammonium acetate buffer (50:20:30, v/v/v), final pH adjust to 5.5 ± 0.02 with ortho phosphoric acid as mobile phase and delivered at a flow rate of 1 ml/min. The UV detection was set at 220 nm. The calibration range was from 2.0 to 30.0 μg/ml. The method was validated in term of linearity (r2>0.98, RSD= 1.958%), precision (RSD=3.757 %) and accuracy. The limit of quantification was 2 μg/ml and the limit of detection was 0.1 μg/ml. The potency of midazolam in marketed products was determined by this method with acceptable precision and reproducibility.