Authors:Venkata Ramana Malipeddi, Rajendra Awasthi, and Kamal Dua
Metoprolol tartrate is rapidly absorbed from both gastric and intestinal regions, after oral administration. To retard the release rate of the metoprolol tartrate, microspheres were prepared with varying concentrations of a mixture containing ethylcellulose and polyethylene glycol-6000. The prepared microspheres were evaluated for various physicochemical characteristics and in vitro drug release. The percent yield of microspheres was in the range of 75.2–87.3%. The particle size of microspheres was found to be in the range of 73.2–85.5 μm. Fourier transform-infrared spectral analysis and differential scanning calorimetry concluded the absence of any interaction between the drug and the carriers. The release time profile of metoprolol tartrate from microspheres in 0.1 N hydrochloric acid solution was to the extent of 33.4–60.2%. The complete release of metoprolol tartrate occurred from MPT-3 and MPT-4 in phosphate buffer solution (pH 7.4) within 8 and 7 h, respectively, whereas the incomplete release (72.3%) occurred from MPT-1. Nearly, the complete release (98.5%) of metoprolol occurred from MPT-2 in 10 h. Formulation MPT-2 would be a preferred formulation. The release of metoprolol involves diffusion rate limited (R2 = 0.9865) as a mechanism from drug release. The prepared microspheres of metoprolol tartrate eliminate the need for multiple dosing and provide patient compliance.
Authors:Kamal Dua, Shakti Dhar Shukla, Terezinha de Jesus Andreoli Pinto, and Philip Michael Hansbro
Considering the various limitations associated with the conventional dosage forms, nanotechnology is gaining increased attention in drug delivery particularly in respiratory medicine and research because of its advantages like targeting effects, improved pharmacotherapy, and patient compliance. This paper provides a quick snapshot about the recent trends and applications of nanotechnology to various translational and formulation scientists working on various respiratory diseases, which can help paving a new path in developing effective drug delivery system.
Authors:Y. T. Kamal, Hasan Soliman Yusufoglu, Prawez Alam, and Ahmed Ibrahim Fouda
In this research, a novel method was developed for the matrix solid phase dispersion (MSPD) followed by high-performance liquid chromatography (HPLC) quantification of four marker constituents (vitamin C, gallic acid, rutin, and ellagic acid) in the freeze-dried pomegranate fruit juice. Various MSPD parameters like type of dispersant, sample–dispersant ratio, solvents, its volume, and time of extraction have been optimized after many trials. Furthermore, HPLC method has been developed and optimized for the analysis of all four components. The HPLC separation was achieved using a 250 × 4.6 mm column, particle size of 5 μm, C18 reverse phase column, with a mobile phase consisting of acetonitrile and 0.05% H3PO4, in gradient elution mode with a mobile phase flow rate of 1 mL/min, using ultraviolet (UV)–visible detection at 254 nm. All calibration curves showed good linear regression (r2 ≥ 0.9925) within test ranges. The extraction recoveries of the marker constituents analyzed by MSPD methods were found as ranging from 97.5% to 103.5%. From comparing the chromatograms, validation data and other parameters like time, labor, and feasibility, we found that MSPD technique was most suitable for the analysis as compared to conventional liquid–liquid extraction technique.
Authors:Laíse de Oliveira Andrade, Rajendra Awasthi, Kamal Dua, and Terezinha de Jesus Andreoli Pinto
During the manufacturing of sterile drugs, it is of the utmost importance to meet the minimum requirements for asepsis recommended by the legislations on good manufacturing practices-based efficient environmental monitoring.
Aims and methods
The availability of relatively simple to use matrix-assisted laser desorption ionization–time of flight mass spectromtomy (MALDI-TOF MS) devices in the last years has changed the laboratory workflows for the microbial identification, mainly in the clinical area. Thus, the objective of this work was to evaluate the suitability of the MALDI-TOF MS technique for the identification of bacteria isolated from the environment of clean rooms used in some stages of the production of a viral vaccine. Eighteen known bacterial species commonly isolated from clean rooms studied were identified by MALDI-TOF technique and by a biochemical technique (BBL Crystal® System).
Performance of MALDI-TOF MS was better than biochemical technique for correct species identifications (88.89% and 38.89%, respectively) and produced less unreliable identification (5.55% and 22.22%).
MALDI-TOF MS can be implemented for routine identification of bacteria in a pharmaceutical quality control laboratory, but as a database-dependent system, maybe some isolated not identified by this technique must be additionally studied and, if appropriate, added to an in-house database.
Authors:Y.T. Kamal, Mhaveer Singh, Shahana Salam, and Sayeed Ahmad
The alternative system of medicines like Unani and Ayurveda is preferred worldwide nowadays due to its therapeutic efficacy, lower side effects, holistic approach, psychological dimensions, and qualitative action of weather and seasonal requirement. A simple procedure is described for the simultaneous extraction and estimation of piperlongumine and piperine in a well-known Unani polyherbal formulation using reversed-phase high-performance liquid chromatography (HPLC). The chromatography was carried out on reversed-phase C18 (250 × 4.6 mm) column with a mobile phase containing acetonitrile—water (50:50 v/v). Detection was accomplished with ultraviolet (UV) detection at λ = 325 nm. The flow rate was kept as 1.0 mL−1. The proposed method was validated according to International Conference on Harmonization (ICH) guidelines for accuracy (94.4–105.0%), precision (0.37–2.17% RSD), and robustness (0.14–2.11% RSD). The limit of detection (LOD) values were found as 30 and 10 ng mL−1, while limit of quantification (LOQ) was 100 and 30 ng mL−1 for piperlongumine and piperine, respectively, which proved the sensitivity of the method satisfactory enough for accurate analysis of the both piperlongumine and piperine.
Authors:K. Pramod, U. K. Ilyas, M. Singh, Y. T. Kamal, S. Ahmad, S. H. Ansari, and J. Ali
High-performance thin-layer chromatography (HPTLC) method for the quantification of eugenol from nanostructured drug delivery systems was successfully developed and validated. The mobile phase consisted of n-hexane:acetone (7:3, v/v), and the densitometric scanning was performed in the absorbance mode at 280 nm. The method was valid with respect to linearity and range, accuracy, precision, specificity, detection limit (DL), and quantitation limit (QL). The linearity of the method was established by a correlation coefficient value of 0.9930 ± 0.0013. The precision was tested by checking intra-day (repeatability) and inter-day (intermediate precision) variations. The method was established to be precise by low relative standard deviation (RSD) values for different concentration of eugenol. The results of the recovery studies of eugenol from preanalyzed samples demonstrated the accuracy of the method. The specificity of the developed method for the analysis of eugenol in the nanoemulsion gel and nanoparticles samples was confirmed by comparing the spectra obtained in standard and sample analysis. The DL and QL were determined to be 31.41 and 95.17 ng band−1, respectively, for the HPTLC method. The forced degradation studies revealed on eugenol established the effectiveness of the developed and validated method. The developed and validated HPTLC method was found to be a stability-indicating one, as indicated by the results of forced degradation studies, for its use during the accelerated stability studies of the nanoemulsion gels and nanoparticles of eugenol.
Authors:Y.T. Kamal, Sayeed Ahmad, Nanjaian Mahadevan, Prawez Alam, Shahana Salam, Yahya I Asiri, Abdullatif Bin Muhsinah, and Abdulrhman Alsayari
A new High Performance Liquid Chromatography–Photodiode Array Detector (HPLC–PDA) method has been developed for the chromatographic separation and simultaneous quantitative determination of nine bioactive compounds, i.e. four phenolic (gallic acid, ellagic acid, chebulinic acid, and tannic acid), two flavanoids (rutin and quercetin), two anthraquinones (sennoside A and B) and one oxygenated hydrocarbon (vitamin C) in a well-known Unani polyherbal formulation namely Itrifal's. Separation was accomplished on a C18 LiChrospher 100 column (5 µm, 250 × 4.6 mm) with a gradient elution and recorded at 254 nm. The results demonstrated that the proposed method is reproducible, accurate, economic, and suitable for the quality control of traditional polyherbal Unani formulations containing complex compounds with different structures such as Itrifals.
Authors:Ottó Szenci, Kamal Touati, Noelita Melo De Sousa, Jean-Luc Hornick, Gijsbert Cornelis Van der Weyden, Marcel Antonie Marie Taverne, and Jean-François Beckers
The aim of this study was to further develop and extensively describe a surgical technique in order to realise long-term fetal blood sampling in the bovine species. Eleven Holstein–Friesian 6- to 8-month pregnant cows (4–10 years old) were used for this study. Gestational age on the day of surgery varied from approximately 180 days (n = 1) to 240 days (minimum: 232 days, maximum 252 days; n = 10). The fetal medial tarsal artery was catheterised in pregnant cows with a polyvinyl catheter in dorsal recumbency under general anaesthesia. Although 5 out of 11 operations (45.5%) performed between 232 and 252 days of gestation were lost due to different causes mainly associated with peritonitis and septicaemia, the mean interval between operations and calvings was 42.5 days (between 27 and 95 days). It is important to emphasise that a well-trained surgical team is needed for bovine fetal cannulation in order to be able to decrease the risk factors during the operations. Due to the fact that after 5 unsuccessful cases none of the pregnancies were lost, this skill can be reached, and our technique can enable bovine fetal blood sampling for long-term endocrinological and physiological investigations before and during parturition.
Authors:Kamal Dua, Venkata Ramana Malipeddi, Jyotsna Madan, Gaurav Gupta, Srikumar Chakravarthi, Rajendra Awasthi, Irene Satiko Kikuchi, and Terezinha De Jesus Andreoli Pinto
Our various previous findings have shown the suitability of norfloxacin in the treatment of bacterial infections and burn wounds in alone as well as in combination with Curcuma longa in various topical (ointments, gels, and creams) and transdermal drug delivery systems.
Aims and methods
Keeping these facts in consideration, we have made an another attempt to prepare semisolid formulations containing 1% w/w of norfloxacin and metronidazole with different bases like Carbopol, polyethylene glycol, and hydroxypropylmethyl cellulose for effective treatment of bacterial infections and burn wounds. The prepared formulations were evaluated for physicochemical parameters, in vitro drug release, antimicrobial activity, and burn wound healing properties.
The prepared formulations were compared with Silver Sulfadiazine cream 1%, USP. Antimicrobial activity of norfloxacin semisolid formulations was found to be equally effective against both aerobic and anaerobic bacteria in comparison to a marketed formulation of Silver Sulfadiazine 1% cream, USP. Based on the burn wound healing property, the prepared norfloxacin semisolid formulation was found to be in good agreement with marketed Silver Sulfadiazine 1% cream, USP.
These findings suggest formulations containing norfloxacin and metronidazole may also prove as an effective alternative for existing remedies in the treatment of bacterial infections and burn wounds.