Pharmaceutical Capsules Research Articles

Tattoo‐Paper Transfer as a Versatile Platform for All‐Printed Organic Edible Electronics

The use of natural or bioinspired materials to develop edible electronic devices is a potentially disruptive technology that can boost point-of-care testing. The technology exploits devices that can be safely ingested, along with pills or even food, and operated from within the gastrointestinal tract. Ingestible electronics can potentially target a significant number of biomedical applications, both as therapeutic and diagnostic tool, and this technology may also impact the food industry, by providing ingestible or food-compatible electronic tags that can "smart" track goods and monitor their quality along the distribution chain. Temporary tattoo-paper is hereby proposed as a simple and versatile platform for the integration of electronics onto food and pharmaceutical capsules. In particular, the fabrication of all-printed organic field-effect transistors on untreated commercial tattoo-paper, and their subsequent transfer and operation on edible substrates with a complex nonplanar geometry is demonstrated.

Determination of Tryptophan in Pharmaceutical Formulations Using a Sequential Injection–Zone Fluidic–Chemiluminescence Tubular Reactor

ABSTRACTTryptophan is an important amino acid for humans with a significant role in cell metabolism. Depletion of tryptophan in the human body may contribute to diseases and development of disorders among the human population. It is, therefore, very important to have a reliable, stable, sustainable, and cost-effective analytical method for the determination of tryptophan. Tryptophan was determined using sequential injection–zone fluidics analysis with luminol–hydrogen peroxide and the Firefly with its unique liquid core waveguide flow-cell design as chemiluminescence tubular reactor with a high-sensitivity photomultiplier tube. This was based on an intense chemiluminescence formation of tryptophan in luminol–hydrogen peroxide inside the tubular reactor for measurement. The chemiluminescence intensity was linear with tryptophan in the range of 1.0 × 10−6 to 1.0 × 10−3 mol/L, and the limit of detection was 7.5 × 10−7 mol/L. The precision for the method was 3.6% (relative standard deviation) for six measurements of 1.0 × 10−4 mol/L tryptophan. The proposed method has been used to determine tryptophan in pharmaceutical formulations. The system is relatively fast for online assays. Eighty seconds are required to complete one cycle providing a throughput of 45 samples/h. The proposed sequential injection analysis–zone fluidics–chemiluminescence system for the assay of tryptophan in certain specific pharmaceutical capsules is simple, reliable, sustainable, and convenient with relatively low-cost consumption of reagents.

Rapid Surface Enhanced Raman Scattering (SERS) Detection of Sibutramine Hydrochloride in Pharmaceutical Capsules with a β-Cyclodextrin- Ag/Polyvivnyl Alcohol Hydrogel Substrate.

Sibutramine hydrochloride (SH) is a banned weight-loss drug, but its illegal addition to health products is still rampant. This suggests a very urgent need for a fast and precise detection method for SH. Surface Enhanced Raman Scattering (SERS) is a promising candidate for this purpose, but the weak affinity between SH and bare metal limits its direct SERS detection. In the present work, β-cyclodextrin was capped in situ onto the surface of Ag nanoparticles to function as a scaffold to capture SH. The obtained Ag nanoparticles were encapsulated into polyvinyl alcohol (PVA) to fabricate a SERS active hydrogel with excellent reproducibility. A facile SERS strategy based on such substrate was proposed for trace SH quantification with a linear range of 7.0–150.0 µg·mL–1, and a detection limit low to 3.0 µg·mL−1. It was applied to analyze seven types of commercial slimming capsules with satisfactory results, showing good prospect for real applications.

Rapid simultaneous determination of indacaterol maleate and glycopyrronium bromide in inhaler capsules using a validated stability-indicating monolithic LC method

BackgroundChronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. A combination of indacaterol maleate with glycopyrronium bromide has recently been approved as a once-daily maintenance therapy in patients with COPD. The very low dose (μg level/capsule) renders the analysis of such products challenges. This study reports for the first time about HPLC method for the quality control of such combination and it is a stability indicating at the same time.ResultsA rapid, simple, precise and reproducible HPLC method was developed and validated for simultaneous determination of indacaterol maleate and glycopyrronium bromide using tenoxicam as an internal standard. The chromatographic separation was achieved on an onyx monolithic C18 column (100 × 4.6 mm) using a mobile phase consisting of acetonitrile and 30 mM phosphate buffer (pH 3.5) (30:70, v/v), run at a flow rate of 2 mL/min with UV detection at 210 nm. The total analysis time was less than 3 min. The HPLC method was validated for linearity, limits of detection and quantitation, precision, accuracy, system suitability and robustness. Calibration curves were obtained in the concentration ranges of 1–44 µg/mL for indacaterol maleate and 0.5–20 µg/mL for glycopyrronium bromide. Stability tests were done through exposure of the analyte solution for different stress conditions and the results indicate no interference of degradants with HPLC method.ConclusionsThe method was successfully applied for the quantitative analysis of indacaterol maleate and glycopyrronium bromide both individually and in a combined pharmaceutical inhaler capsules to support the quality control and to assure the therapeutic efficacy of the two drugs. The simple procedure involved in sample preparation and the short run-time added the important property of high throughput to the method. Graphical abstractChemical structures and representative HPLC chromatogram of indacaterol maleate (IND; 22 μg/mL), glycopyrronium bromide (GLY; 10 μg/mL) and tenoxicam (IS, 15μg/mL) in commercial capsules.

New self-healing techniques for cement-based materials

Abstract: In recent years, researches concerning cement-based materials has been focused not only on the strength and the toughness but also on the durability. In fact, the interest on concrete's self-healing process is increasing, due to the rapidly deterioration of that material which tends to crack and thus quickly deteriorate. In this paper, a new self-healing technology for cement-based materials is proposed. This technology is based on the encapsulation method of repairing agent inserted in randomly distributed shell inside the material during its preparation. Two different kind of shells were used: glass spheres and pharmaceutical capsules. The material the shells are made of has to be endowed with a series of fundamental characteristics. That material has to be inert with respect to the repair agent so that it doesn't react with it, resisting to the severe stress condition that the shells undergo during the mixing, and at the same time being capable of breaking down when the crack intercept them, having a good compatibility with the cement mixture. The results demonstrate that it is possible to use this kind of shell to encapsulate the repairing agent: the crack breaks them and they release the healing agent, which allows patching up the crack.

Quality Inspection of Dented Capsule using Curve Fitting-based Image Segmentation

Automatic quality inspection by computer vision can be applied and give a solution to the pharmaceutical industry field. Pharmaceutical capsule can be easily affected by flaws like dents, cracks, holes, etc. In order to solve the quality inspection problem, it is required computationally efficient image processing technique like thresholding, boundary edge detection and segmentation and some automated systems are available but they are very expensive to use. In this paper, we have developed a dented capsule image processing technique using edge-based image segmentation, TLS(Total Least Squares) curve fitting technique and adopted low cost camera module for capsule image capturing. We have tested and evaluated the accuracy, training and testing time of the classification recognition algorithms like PCA(Principal Component Analysis), ICA(Independent Component Analysis) and SVM(Support Vector Machine) to show the performance. With the result, PCA, ICA has low accuracy, but SVM has good accuracy to use for classifying the dented capsule.

Color Defect Detection of Pharmaceutical Capsules using Histogram based Thresholding

Color Defect Detection of Pharmaceutical Capsules using Histogram based Thresholding

Functional properties of dually modified sago starch/κ-carrageenan films: An alternative to gelatin in pharmaceutical capsules

The aim of this study was development a composite film based on sago starch and κ-carrageenan to find a gelatin alternative in the pharmaceutical capsules processing. Hydrolyzed-Hydroxypropylated (dually modified) sago starch was mixed with κ-carrageenan (0.25, 0.5, 0.75, and 1%). The drying kinetics, thermomechanical, physicochemical, and barrier properties of composite films were estimated and compared with bovine gelatin. Results show that drying kinetics and mechanical properties of the composite films were comparable to those of gelatin. The water vapor permeability and moisture content of the composite films were lower than those of gelatin. The solubility of the composite films was higher than that of gelatin, and the composite films were more stable at higher relative humidity than were the gelatin films. These results show that dually modified sago starch in combination with κ-carrageenan has properties similar to those of gelatin, thus proposed system can be used in pharmaceutical capsules processes.

Development of Square Wave Voltammetric Method for the Electrochemical Determination of Pregabalin as Pregabalin-Cu(II) Complex Using Graphite Electrode

In the present study, a square wave voltammetric (SWV) method was developed for the determination of pregabalin (PREG) in commercial drugs and biological samples as PREG-Cu(II) complex using graphite working electrode. A well-defined voltammetric signal of the complex was observed at nearly – 200 mV, by using Britton Robinson supporting electrolyte (B-R) at pH 7.5. There were some analytical conditions that have been evaluated through this research such as accumulation time and potential, scan rate, amplitude, frequency, and stirring rate to obtain a good voltammetric peak and high current without any overlap. In addition, some metal ions as potential interferences; such as Zn(II), Ni(II) and Cd(II) have been added at different concentrations to evaluate their effects on the voltammetric signal for PREG-Cu(II) complex. The SWV performance was investigated by monitoring parameters such as calibration curve, detection limit, reproducibility, stability and recovery. The calibration curve was studied over the range 5.0 ´10 -8 –1.0 ´10 -6 mol L -1 of (PREG) and 5.0 ´ 10 -5 mol L -1 of copper ion (n=8, r 2 = 0.99), yielded a linear relationship between voltammograms and complex concentrations. The sensitivity of SWV method was evaluated by calculating the detection limit which was found to be 6.5´10 -9 mol L -1 . The reproducibility, stability and recovery were studied for 5.0 х10 -7 mol L -1 of (PREG) and 5.0 х 10 -5 mol L -1 of copper ion, yielded a relative standard deviation (RSD%) that was calculated to be 0.4% and good stability for the voltammetric signal, while the recovery was recorded to be 93±1.23%. The analytical voltammetric technique (SWV) was applied to determine PREG-Cu(II) complex in pharmaceutical capsules and biological fluids, specifically urine and plasma, where it gave recoveries of 90±1.0%, 89±1.23% and 86±1.23%, respectively.

Determination of nilotinib in spiked plasma, urine, and capsules by high-performance liquid chromatography with fluorimetric detection

A precise and sensitive reversed phase high-performance thin-layer chromatography (RP-HPLC) method was developed for the determination of nilotinib (NTB) in spiked plasma, urine, and pharmaceutical capsule formulation. The method was based on derivatization NTB with 4-chloro-7-nitrobenzofurazan (NBD-Cl) in the borax buffer (pH 9). The method employs an isocratic elution using acetonitrile and 10 mM orthophosphoric acid (40:60 v/v) as a mobile phase and an C18 column (4.6 mm × 250 mm, 5 μm, Waters Symmetry), with a fluorescence detector (λex: 447 nm, λem: 530 nm). The method validation was performed with respect to linearity, recovery, accuracy, precision, and stability. The linear ranges were 100–600 ng mL−1 in standard solution, plasma, and urine. Correlation coefficients (r2) were higher than 0.9997 for all of the analytes, indicating good linear relationship. The percentage recovery was 87.89% for plasma, 95.35% for urine, and 96.07% for capsules.

Development and Validation of a Stability-Indicating RP-HPLC Method for the Estimation of Indomethacin in Pharmaceutical Capsule Formulation

Purpose : A new stability-indicating RP-HPLC assay method for estimation of indomethacin and its degradation products formed under various stress conditions was developed and validated for routine analysis of indomethacin in its marketed dosage forms. Methodology : The method uses a volatile buffer and could be extended for LC-MS studies. The separation was carried out on Zorbax Eclipse Plus C18, 3.5 μm (4.6 mm × 100 mm) column with acetonitrile: 10 mM sodium acetate buffer pH 4, 60:40% v/v as the mobile phase at the flow rate of 0.5 ml/min with detection carried out using UV-Visible PDA detector at 226 nm. The retention time of indomethacin was 5 min and linearity was observed in the concentration range of 7.5-75 μg/ml. The developed method was validated as per the ICH guidelines. The drug was subjected to various stress conditions of acid and base hydrolysis, oxidation, photolysis, thermal degradation and neutral condition. Findings : Considerable degradation was found under all stress conditions and the degradation products were well resolved from indomethacin in the proposed HPLC method. Conclusion: The new method could be used for routine analysis of indomethacin in its dosage forms. The model used for stress degradation studies is simple and could be extended for study of other drug molecules.

Print registration for automated visual inspection of transparent pharmaceutical capsules

This paper addresses a challenging problem of visual inspection of transparent pharmaceutical capsules, where print registration is used to determine the capsule's print region. The determination of the print region allows for reliable detection of defects both on the print region and on the rest of the capsule's surface. On transparent capsules, both the print on the front and the print on the back of a capsule are concurrently visible. Moreover, the print on the back may be partially or entirely occluded by the powder inside the capsule. All this causes that the print registration methods used for opaque capsules do not achieve adequate performance. In this paper, we present a novel registration method designed specifically for transparent capsules. The method utilizes a template matching technique with a new similarity measure that considers the specific properties of transparent capsules to increase the registration robustness. Additionally, we present a registration refinement step that reduces the effect of possible print deformations and image distortions. The performance of the method was evaluated in terms of robustness, accuracy and speed on large image sets of four different radial prints. The new method shows highly improved robustness (>98.6 %) compared to the method based on normalized cross-correlation (>72 %) and the method based on feature matching (>80 %). Furthermore, the additional refinement step improves the registration accuracy. Although the execution time is raised from 3 to 11 ms, it still meets the usual speed requirements.

PVC-zeolite nanoparticle-surfactant anion exchanger membrane: preparation, characterization, and its application in development of ion-selective electrode for detection of sulfate

A modified PVC electrode with tetradecyltrimethyl ammonium surfactant-clinoptilolite nanoparticles exhibited Nernstian response (29.9 ± 0.9 mV per decade) for sulfate ions in a working concentration range of 1.0 × 10− 7 − 1.0 × 10− 1 mol × L− 1 sulfate (detection limit of 7.0 × 10− 8 mol L− 1 sulfate). The sensor had a fast response time of 7–10 s and can be used for at least 8 weeks without any divergence in potential. The electrode can be used in the pH range of 4–10. The proposed electrode successfully used for determination of sulfate in zinc sulfate pharmaceutical capsule and as indicator electrode in titration of sulfate with barium chloride.

Spectrofluorimetric Determination of α-Tocopherol in Capsules and Human Plasma.

A simple, sensitive and rapid spectrofluorimetric method for determination of α-tocopherol in pharmaceutical capsule and human plasma was developed and validated. The native fluorescence of α-tocopherol was measured at 334 nm with excitation at 291 nm, after extraction of α-tocopherol from human plasma hexane:dichloromethane mixture. The calibration curves were linear (R≥0.9993) in the concentration range of 0.25-2.5 μg/ml of α-tocopherol in both standard solutions and plasma samples. The developed method was directly and easily applied for determination of α-tocopherol in the plasma of healthy volunteers and different type of bladder cancer and stomach cancer patients and also pharmaceutical capsule.

Photodegradation of cotrimaxazole by clinoptilolite-supported nickel oxide

Photocatalytic activity of NiO incorporated into clinoptilolite nanoparticles (NiO-NCP) was studied in the photodegradation of cotrimaxazole pharmaceutical capsule (a mixture of trimethoprim and sulfamethoxazole) in aqueous system under medium Hg-lamp irradiation. Samples were characterized by XRD, FT-IR, UV–Vis–DRS, TEM and BET. The effects of some key experimental parameters affecting the photodegradation extent of the pollutant were studied and the best results were obtained at 13.2% NiO loaded onto NCP, 0.2gL−1 of the NiO13.2%-NCP catalyst, 50 folds diluted cotrimaxazole solution at pH 3. COD of the pollutant solution was decreased from its initial value of 1930–700mgL−1 during 4h photodegradation process (corresponds to 64% degradation of cotrimaxazole). The peak area of the main peak in HPLC chromatogram was also decreased during the irradiation process. HPLC and COD results are in accordance with decrease in UV–vis absorbance during the photodegradation process, confirming the degradation of cotrimaxazole into smaller fragments.

Colorimetric Method for Determination of some 1,4-Dihydropyridine Drugs in their Tablets and Capsules

A simple, accurate and selective colorimetric method was developed and validated for determination of five 1,4-dihydropyridine drugs (1,4-DHP) using Tetrabutylammonium hydroxide reagent (TBAH). The proposed method was based on addition of TBAH to the studied drugs then produced yellow colors were measured spectrophotometrically. Different variables affecting the reactions conditions carefully studied and optimized and under the optimum conditions, Beer's law was obeyed in the concentration range of 2.50-40.0 µg/mL and the limits of detection were ranged from 0.750-1.956 µg/mL. The proposed method was successfully extended to pharmaceutical preparations tablets or capsules and the results which obtained were comparable with that obtained by the reference methods.

Determination of Acidic Dyes in Pharmaceutical Capsules by Solid-Phase Extraction and High-Performance Liquid Chromatography

ABSTRACTA rapid and simple method was established for the determination of acidic dyes in pharmaceutical capsules using solid-phase extraction and high-performance liquid chromatography with a diode array detector. The capsules were dissolved in water using an ultrasonic bath at 55 ± 5°C, and pH was adjusted to 1 with 0.2 mol/L hydrochloric acid. The resulting solution was purified using a weak anion exchange solid-phase extraction cartridge. Chromatographic separation was performed on a reversed phase C18 column with gradient elution using acetonitrile and 20 mmol/L aqueous ammonium acetate (pH = 4.5) as the mobile phase. The chromatography was monitored at 420, 480, 520, and 600 nm. Under the optimized conditions, the recoveries of the analytes were from 60.5 ± 1.59 to 99.1 ± 0.84%. The intraday and interday relative standard deviations were from 0.29 to 10.6% and from 1.08 to 10.8%, respectively. The limits of quantification were between 0.11 and 0.50 µg/g.

SUITABILITY OF CAPSULE AS A PADDY COATING MATERIAL FOR THE SYSTEM OF RICE INTENSIFICATION (SRI)

One of the challenges faced by farmers in adopting the system of rice intensification is the seed establishment required high labor demand. This research aims at providing an alternative to seedling transplanting for the system of rice intensification. In this research the paddy seed was enhanced with the use of pharmaceutical capsule as a seed coating material for ease of seed singulation and suitability in handling by a conventional direct seeding technique. It covers the study of capsules as a suitable paddy seed coating material. The solubility of starch and gelatin capsules in water was studied at three different temperatures of 25oC, 35oC, and 45oC. Three paddy seed treatments of dry seeds, primed seed, and pre germinated were each placed in to the capsule at the ratio of 1:1 and planted in the soil with three replications. The planted seeds were irrigated two times daily for a period of 10 days within which the germination and emergence were recorded on daily bases. Gelatin capsule was found to be soluble in water at temperature of 45oC and above. Starch capsule on the other hand was found to be soluble at temperatures of 25oC which made it the more suitable paddy coating material in comparison with the gelatin capsule. The germination and emergence results of starch capsule coated paddy were found to be 95%, 83%, and 58% for the pre germinated, primed, and dry paddy seeds respectively.

Color Defect Detection of Pharmaceutical Capsules using Histogram based Thresholding

In this paper, a new method of inspecting pharmaceutical capsules aesthetic defects is proposed using color image processing. After an image is taken, median filtering is performed. Then the region based statistics is calculated to acquire the largest area of pharmaceutical capsule from the image. After that RGB image is transferred into R plane, G plane and B plane. Then histogram of each plane is calculated. Further by setting thresholding value of each plane, mask of each plane is determined. Color segmentation of image is achieved by combining mask of each plane. Experiments are conducted with the quality inspection of pharmaceutical capsules. Time is also taken as major parameter of the system. Experiment results show the reliability and feasibility of proposed method as time and quality control are two main parameters in industry. The proposed paper present an application to detect defect related to color of pharmaceutical capsules which can be adapted to other practical applications for automated visual inspection using image processing techniques.

In-process and Finished Products Quality Control Tests for Pharmaceutical Capsules According to Pharmacopoeias

The quality of pharmaceutical products is essential to assure the maximum level of patient’s satisfaction. The most important criteria for quality of any drug in dosage form are its safety, potency, efficacy, stability, patient acceptability and regulatory compliance. Different parameters of quality control of pharmaceutical products can ensure the quality, bioavailability and optimal therapeutic activity. The maintenance of quality with continuous improvement in facilities is very important in pharmaceutical industries because it is directly related to healthcare system. The quality of a pharmaceutical capsule needs to be designed from the product development stage. In-process quality control (IPQC) tests are done with a view to remove error from every stage in production and maintain the quality of the final product with the compendial standards as specified in the pharmacopoeias. The quality of final products depends on in-process control (IPC) tests, because it helps to incorporate excellence within the products. The qualitative and quantitative parameters of pharmaceuticals products are checked by finished product quality controls (FPQC) tests. The purpose of this study is to provide concise information on the in-process and finished products quality control tests for pharmaceutical capsules as per different pharmacopoeias.