Verification of the mixing processes of the active pharmaceutical ingredient, excipient and lubricant in a pharmaceutical formulation using a resonant acoustic mixing technology

RSC Advances ◽  
2016 ◽  
Vol 6 (90) ◽  
pp. 87049-87057 ◽  
Author(s):  
Ryoma Tanaka ◽  
Naoyuki Takahashi ◽  
Yasuaki Nakamura ◽  
Yusuke Hattori ◽  
Kazuhide Ashizawa ◽  
...  
Keyword(s):  
Chemical Stability ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Pharmaceutical Formulation ◽  
Pharmaceutical Manufacturing ◽  
High Quality ◽  
Mixing Processes ◽  
Resonant Acoustic Mixing

Mixing processes are important for making high-quality pharmaceutical formulations and are related to dissolution and chemical stability in pharmaceutical manufacturing.

Sequential Injection Chromatography with Monolithic Column for Phenothiazines Assay in Human Urine and Pharmaceutical Formulations

2020 ◽  
Vol 16 (7) ◽  
pp. 967-975
Author(s):  
Abubakr M. Idris
Keyword(s):  
Phase Composition ◽  
Human Urine ◽  
Mobile Phase ◽  
Monolithic Column ◽  
Pharmaceutical Formulations ◽  
Pharmaceutical Formulation ◽  
Assay Method ◽  
Sequential Injection ◽  
Mobile Phase Composition ◽  
Sequential Injection Chromatography

Methods: Sequential injection chromatography (SIC) with monolithic column has been proposed with potential benefits for separation and quantification. Objective: To utilize SIC to develop a new assay method for the separation and quantification of some phenothiazines (promethazine, chlorpromazine and perphenazine) in human urine and synthetic pharmaceutical formulations. Methods: The 32 full-factorial design was adopted to study the effect of mobile phase composition on separation efficiency, retention time, peak height and baseline. The separation was conducted on a C18 monolithic column (100 × 4.6 mm) using a mobile phase composition of phosphate: acetonitrile:methanol (60:28:12) at pH 4.0. The detection was carried out using a miniaturized fiber optic spectrometer at 250 nm. Results: Satisfactory analytical features, including number of theoretical plates (1809-6232), peak symmetry (1.0-1.3), recovery (95.5-99.1% in pharmaceutical formulations and 91.6-94.7% in urine), intra-day precision (0.36-1.60% for pharmaceutical formulation and 2.96-3.67 for urine), inter-day precision (1.47-2.28% for pharmaceutical formulation), limits of detection (0.23-0.88 μg/ml) and limits of quantification (0.77-2.90 μg/ml), were obtained. Conclusion: The remarkable advantages of the proposed SIC method are the inexpensiveness in terms of instrumentation and reagent consumption.

Comparative Study for the Assay of Plant Derived Chemicals in Pharmaceutical Formulation Using Methods Dependent on Factorized Spectra

2021 ◽  
Author(s):  
Nesma M Fahmy ◽  
Adel M Michael
Keyword(s):  
Pharmaceutical Formulations ◽  
Pharmaceutical Formulation ◽  
Ternary Mixtures ◽  
Ratio Method ◽  
The Novel ◽  
Naturally Occurring ◽  
Accuracy And Precision ◽  
Validation Parameters ◽  
Significant Difference

Abstract Background Modern built-in spectrophotometer software supporting mathematical processes provided a solution for increasing selectivity for multicomponent mixtures. Objective Simultaneous spectrophotometric determination of the three naturally occurring antioxidants—rutin(RUT), hesperidin(HES), and ascorbic acid(ASC)—in bulk forms and combined pharmaceutical formulation. Method This was achieved by factorized zero order method (FZM), factorized derivative method (FD1M), and factorized derivative ratio method (FDRM), coupled with spectrum subtraction(SS). Results Mathematical filtration techniques allowed each component to be obtained separately in either its zero, first, or derivative ratio form, allowing the resolution of spectra typical to the pure components present in Vitamin C Forte® tablets. The proposed methods were applied over a concentration range of 2–50, 2–30, and 10–100 µg/mL for RUT, HES, and ASC, respectively. Conclusions Recent methods for the analysis of binary mixtures, FZM and FD1M, were successfully applied for the analysis of ternary mixtures and compared to the novel FDRM. All were revealed to be specific and sensitive with successful application on pharmaceutical formulations. Validation parameters were evaluated in accordance with the International Conference on Harmonization guidelines. Statistical results were satisfactory, revealing no significant difference regarding accuracy and precision. Highlights Factorized methods enabled the resolution of spectra identical to those of pure drugs present in mixtures. Overlapped spectra of ternary mixtures could be resolved by spectrum subtraction coupled FDRM (SS-FDRM) or by successive application of FZM and FD1M.

QBD BASED RP-HPLC METHOD FOR SCREENING AND ANALYSIS OF TELAPRAVIR AND 7 OTHER ANTIRETROVIRAL AGENTS

INDIAN DRUGS ◽  
2015 ◽  
Vol 52 (02) ◽  
pp. 20-33
Author(s):  
N. S Kumar ◽  
◽  
R Kumaraswamy ◽  
S. Shantikumar ◽  
D. Paul
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Hplc Method ◽  
Array Detector ◽  
Simultaneous Estimation ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Full Factorial

The present study describes the separation and simultaneous estimation of eight anti-retroviral drugs, namely, Telaprevir (TPV), Emtricitabine (ECB), Fosamprenavir (FANV), Tenofavir (TNF), Ritonavir (RNV), Raltegravir (RGV) and Oseltamivir (OSMV) and Zidovudine (ZDV) as an active pharmaceutical ingredient, by RP-HPLC method by applying the principles of Quality by Design (QbD). An application of DoE (Design of Experiments) full factorial design was used for initial screening and optimization. The final optimized method consists of separation being carried out on a Fortis C18 column (150 mm × 4.6 mm, 5μ particle size) using acetonitrile and 10 mm ammonium formate buffer (pH 3 adjusted with formic acid) using a gradient program. The quantitative evaluation was performed with a diode array detector at 251 nm and 230 nm with a flow rate of 1 mL min–1. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the International Conference on Harmonization (ICH) guidelines. The method is selective, precise, robust and accurate and can be used for routine analysis of pharmaceutical formulations in quality control and counterfeit screening.

scholarly journals Low-Content Quantitation in Entecavir Tablets Using 1064 nm Raman Spectroscopy

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Yanlei Kang ◽  
Yushan Zhou ◽  
Qiaoyu Wu ◽  
Ning Wang ◽  
Jianguang Zhou
Keyword(s):  
Raman Spectroscopy ◽  
Limit Of Detection ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Difficult Problem ◽  
Excitation Wavelength ◽  
Standard Normal Variate ◽  
First Choice ◽  
Standard Normal ◽  
Calibration Samples

The nondestructive and high sensitive analysis of a low content of an active pharmaceutical ingredient (API) was a difficult problem, especially in a complex system of pharmaceutical formulations. In this paper, a rapid and no sample preparation method was developed, which used a 1064 nm Raman spectrometer to detect entecavir monohydrate (ETV-H) in Baraclude tablets. Entecavir was a drug approved by FDA for the treatment of chronic hepatitis B and became the first choice in the market. The wavelength selection results displayed that the signal-to-background ratio of the Raman spectrum with 1064 nm excitation wavelength was 14 times that of the commonly used 785 nm wavelength. The partial least squares (PLS) method was used to calibrate concentration models containing 0.1% to 1.0% w/w% ETV-H in calibration set samples. Different preprocessing methods were used to eliminate the background interference and extract more spectral information. Calibration samples were used to choose the best performing model. Then, all the calibration samples combined with the best performing models’ parameters successfully predicted the content of ETV-H in Baraclude tablets. Combining baseline processing and standard normal variate (SNV) with PLS, the model showed a good result with an R2 of 0.973, RMSEC of 0.05%, and RMSEP of 0.03% on the spectral region of 1350–1700 cm−1. The limit of detection of this model was 0.17%. These results showed that 1064 nm Raman spectroscopy technology could be an alternative analytical procedure to quantify low-content API in intact tablets.

Application of Mid-Infrared Spectroscopy to the Development and Transfer of a Manufacturing Process for an Active Pharmaceutical Ingredient

2012 ◽  
Vol 66 (5) ◽  
pp. 574-579 ◽  
Author(s):  
Ian M. Clegg ◽  
Adrian M. Daly ◽  
Craig Donnelly ◽  
Ruth Hardy ◽  
Denise Harris ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Chemical Transformation ◽  
Manufacturing Process ◽  
Active Pharmaceutical Ingredient ◽  
Pharmaceutical Manufacturing ◽  
Process Data ◽  
Mid Infrared ◽  
Mid Infrared Spectroscopy ◽  
Whole Process

The use of in situ mid-infrared spectroscopy to support the development of a pharmaceutical manufacturing process is disclosed. Data on this two-stage telescoped reaction from several reaction scales (<50 mL to 1600 liters) and at multiple manufacturing locations is shown. In addition to providing data on both reactions in the telescope, the mid-IR data has been used to monitor an intermediate distillation operation and therefore it has been possible to profile the whole process. Data is also shown on aliquot addition during the first chemical transformation, which is used to check the instrumentation.

scholarly journals APPLICATION OF LIQUID CHROMATOGRAPHY COUPLED WITH MASS SPECTROMETRY IN THE IMPURITY PROFILING OF DRUG SUBSTANCES AND PRODUCTS

2018 ◽  
Vol 11 (5) ◽  
pp. 30
Author(s):  
Akshatha H S ◽  
Gurupadayya Bm
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
High Sensitivity ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Hyphenated Techniques ◽  
Drug Substances ◽  
Impurity Profiling ◽  
Short Period

As the drug safety and efficacy is hampered in the presence of an impurity, the international regulatory agencies laid down stringent limits for the control of impurities in the active pharmaceutical ingredient and pharmaceutical formulations. The conventional approaches lack the characterization of impurities in trace levels, due to sensitivity issues, hyphenated techniques are preferred. Among the modern hyphenated techniques, liquid chromatography-mass spectrometry (LC-MS) has high sensitivity and can analyze large number of organic compounds in a short period of time. In the present study, the impurity profiling of various drug substances and products using LC-MS about past 6 years were retrospect for its importance, instrumentations, and applications.

scholarly journals EVALUATION OF THE PRESENCE OF POLYMORPHIC FORMS AND INFLUENCE ON THE DISSOLUTION PROFILE OF TENOXICAM IN ACTIVE PHARMACEUTICAL INGREDIENT AND FORMULATIONS

2018 ◽  
Vol 2 (2) ◽  
pp. 27-36
Author(s):  
Aline Taís Fries ◽  
Natália Olegário ◽  
Sarah Chagas Campanharo ◽  
Vitor Paulo Pereira ◽  
Martin Steppe
Keyword(s):  
Chemical Properties ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Xrd Analysis ◽  
Pharmaceutical Products ◽  
In Vitro Dissolution ◽  
Dissolution Profile ◽  
Crystalline Structures ◽  
Polymorphic Forms

Polymorphism is a relatively common phenomenon among pharmaceutical compounds, and one of the main aspects to be considered in the production and development of medications. The investigation of polymorphism associated with oxicams, a group belonging to the class of non-steroidal anti-inflammatory drugs (NSAIDs) has increased in recent years and, in the case of tenoxicam, the existence of four polymorphic forms is reported in the literature. The objective of this study was to characterize the presence of different polymorphic forms of tenoxicam in active pharmaceutical ingredient and oral pharmaceutical formulations, as well as to evaluate the influence on in vitro dissolution. The characterization of the three samples of pharmaceutical ingredient of tenoxicam from different suppliers by X-Ray Diffraction (XRD), Infrared (IR) and dissolution profile indicated the presence of a form III crystalline structure, without presenting significant differences between the in vitro dissolution profiles analyzed, and a Dissolution Efficiency (DE%) of 60.30%, 60.70% and 72.34%, respectively. When the four pharmaceutical specialties of tenoxicam were submitted to XRD analysis, they also presented form III crystalline structures. Despite this, the formulations presented different dissolution profiles and a DE% of 75.23%, 83.69%, 78.19% and 90.63%, respectively, without compromising their quality. However, often polymorphism affects physico-chemical properties of drugs, showing the importance of studying this phenomenon, by correlating the presence of crystalline structures to alterations in the quality of active ingredients and pharmaceutical products.

Biopharmaceutical and pharmacokinetic aspects of hopantenic acid in pediatric pharmacotherapy

2021 ◽  
pp. 9-14
Author(s):  
Cristina Ciobanu ◽  
◽  
Diana Guranda ◽  
Valentin Oprea ◽  
◽  
...  
Keyword(s):  
Drug Treatment ◽  
Children And Adolescents ◽  
Neurological Diseases ◽  
Pharmaceutical Formulations ◽  
Pharmacokinetic Parameters ◽  
High Quality ◽  
Analgesic Effects ◽  
Starting Point ◽  
Current Task ◽  
A Current

The development of efficient, high-quality, harmless and affordable pharmaceutical forms for drug treatment in pediatrics is a current task of contemporary pharmacy. Currently, psychiatrists and neurologists from various curative-prophylactic institutions prescribe for children and adolescents nootropic preparations in the form of tablets, powders and syrups, in various neurological diseases, the share of which, according to national and international statistics, is constantly increasing. Currently, the prescription of hopanthenic acid is gaining popularity, thanks to its neuroprotective, neurotrophic, neurometabolic, antidepressant, anxiolytic and analgesic effects. The presented paper has as starting point the analysis of the structural-molecular properties of hopanthenic acid, exposed by biopharmaceutical study, pharmacokinetic parameters and strategies for optimizing pharmaceutical formulations with gastric release.

Sedimentary characteristics and genetic mechanisms of high-quality reservoirs in a mixed siliciclastic-carbonate system in the Qinhuangdao area, Bohai Sea, China

2020 ◽  
Vol 8 (2) ◽  
pp. SF95-SF111
Author(s):  
Yongan Xue ◽  
Chengmin Niu ◽  
Wei Xu ◽  
Xiaojun Pang ◽  
Li Zhang
Keyword(s):  
Bohai Sea ◽  
Genetic Model ◽  
Thermal Evolution ◽  
Critical Factor ◽  
Carbonate Sediments ◽  
High Quality ◽  
Mixing Processes ◽  
Sedimentary Characteristics ◽  
Shahejie Formation ◽  
Mixed Sediments

Mixed siliciclastic-carbonate sediments occur broadly in modern and ancient systems. Studies on mixing processes began in shallow shelf environments; however, the genetic model of marine mixed sediments is difficult to apply to continental rift basins due to the complex palaeogeographic environment. We identified three mixing types in the first and second members of the Palaeogene Shahejie Formation (E2s1–2) in the Qinhuangdao area of the Bohai Sea: (1) mixed fan delta, (2) retrogradation mixed sheet, and (3) mixed sheet without siliciclastic influx. Tectonic stability, arid climate, and saline lakes are prerequisite conditions for the development of mixed sediments, whereas the palaeogeomorphologic unit should be the critical factor. We also concluded that the primary sedimentary material contains near-source coarse terrestrial debris, and the advantageous lithologic facies producing biological components are the foundation for high-quality mixed reservoirs, which are characterized by thick layers and favorable porosities and permeabilities. The micritic coatings and early dolomitization against the background of a saline lake environment favored the preservation of primary pores, whereas the leaching by atmospheric water and organic acid erosion during thermal evolution of the source rock created many secondary pores. In addition, hydrocarbon charging protected the reservoir space from carbonate cementation.

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