- Nano Spray Drying for Encapsulation of Pharmaceuticals. [Review]
- IJInt J Pharm 2018 May 17
- Many pharmaceuticals such as pills, capsules, or tablets are prepared in a dried and powdered form. In this field, spray drying plays a critical role to convert liquid pharmaceutical formulations int...
Many pharmaceuticals such as pills, capsules, or tablets are prepared in a dried and powdered form. In this field, spray drying plays a critical role to convert liquid pharmaceutical formulations into powders. In addition, in many cases it is necessary to encapsulate bioactive drugs into wall materials to protect them against harsh process and environmental conditions, as well as to deliver the drug to the right place and at the correct time within the body. Thus, spray drying is a common process used for encapsulation of pharmaceuticals. In view of the rapid progress of nanoencapsulation techniques in pharmaceutics, nano spray drying is used to improve drug formulation and delivery. The nano spray dryer developed in the recent years provides ultrafine powders at nanoscale and high product yields. In this paper, after explaining the concept of nano spray drying and understanding the key elements of the equipment, the influence of the process parameters on the final powders properties, like particle size, morphology, encapsulation efficiency, drug loading and release, will be discussed. Then, numerous application examples are reviewed for nano spray drying and encapsulation of various drugs in the early stages of product development along with a brief overview of the obtained results and characterization techniques.
- Screening method for rapid classification of psychoactive substances in illicit tablets using mid infrared spectroscopy and PLS-DA. [Journal Article]
- FSForensic Sci Int 2018 May 09; 288:227-235
- Several new psychoactive substances (NPS) have reached the illegal drug market in recent years, and ecstasy-like tablets are one of the forms affected by this change. Cathinones and tryptamines have ...
Several new psychoactive substances (NPS) have reached the illegal drug market in recent years, and ecstasy-like tablets are one of the forms affected by this change. Cathinones and tryptamines have increasingly been found in ecstasy-like seized samples as well as other amphetamine type stimulants. A presumptive method for identifying different drugs in seized ecstasy tablets (n=92) using ATR-FTIR (attenuated total reflectance - Fourier transform infrared spectroscopy) and PLS-DA (partial least squares discriminant analysis) was developed. A hierarchical strategy of sequential modeling was performed with PLS-DA. The main model discriminated four classes: 5-MeO-MIPT, methylenedioxyamphetamines (MDMA and MDA), methamphetamine, and cathinones. Two submodels were built to identify drugs present in MDs and cathinones classes. Models were validated through the estimate of figures of merit. The average reliability rate (RLR) of the main model was 96.8% and accordance (ACC) was 100%. For the submodels, RLR and ACC were 100%. The reliability of the models was corroborated through their spectral interpretation. Thus, spectral assignments were performed by associating informative vectors of each specific modeled class to the respective drugs. The developed method is simple, fast, and can be applied to the forensic laboratory routine, leading to objective results reports useful for forensic scientists and law enforcement.
- Specific stability indicating spectrofluorimetric method for determination of ledipasvir in the presence of its confirmed degradation products; application in human plasma. [Journal Article]
- SASpectrochim Acta A Mol Biomol Spectrosc 2018 May 16; 202:50-57
- A rapid and specific spectrofluorimetric method with higher sensitivity was developed for determination of ledipasvir (LDS) in tablets and human plasma. The proposed method relies on hydrogen bonding...
A rapid and specific spectrofluorimetric method with higher sensitivity was developed for determination of ledipasvir (LDS) in tablets and human plasma. The proposed method relies on hydrogen bonding formations between the hydroxyl groups of polyoxyethylene 50 stearate and LDS, causing significant enhancement of its native fluorescence. The fluorescence intensity was measured at 430 nm after excitation at 340 nm. The fluorescence-concentration plot was rectilinear over the range 1-400 ng mL-1 with detection and quantification limits of 0.25 and 1.10 ng mL-1, respectively. The high sensitivity of the proposed method permits its application for ledipasvir determinations in real human plasma even in the presence of co-administered drugs sofosbuvir and ribavirin. Moreover, the proposed method was further extended to stability studies of ledipasvir after exposure to different forced degradation conditions according to ICH guidelines, along with the structural elucidation of its degradation products utilizing IR and Mass spectra. A proposal for the degradation pathways was presented.
- Deformation behavior of crystallized mannitol during compression using a rotary tablet press simulator. [Journal Article]
- IJInt J Pharm 2018 May 16
- Mannitol is commonly used as a pharmaceutical excipient for tablets; the most widely used oral dosage form for drug delivery. For tableting, mannitol is provided in two different forms: native crysta...
Mannitol is commonly used as a pharmaceutical excipient for tablets; the most widely used oral dosage form for drug delivery. For tableting, mannitol is provided in two different forms: native crystals and textured particles. In order to optimize its formulation, a good understanding of the mechanical behavior mechanism of mannitol is necessary. Thus, the aim of this study is to evaluate the deformation mechanism of native mannitol crystals presenting different particle sizes. Pharmaco-technical and compression studies were performed using mannitol with different mean diameters (160 µm, 50 µm and 25 µm). Lactose (monohydrate) and microcrystalline cellulose were used as brittle and plastic reference materials, respectively. Tableting tests and mathematical models, HECKEL and WALKER, were used to study the deformation mechanism of mannitol (β). Mean Yield Pressure (Py) and WALKER coefficient (W) values showed that the studied crystalline mannitol presents a deformation mechanism close to brittle material. A particle-size analyzer was used at different pulverization pressures to show the high sensibility of the mannitol particles to fragmentation when exposed to high pressures, especially for particles presenting 160 µm size. Scanning Electron Microscopy (SEM) was used to show the fragmentation after high-pressure measurements.
- Effect of deferasirox + erythropoietin vs erythropoietin on erythroid response in Low/Int-1-risk MDS patients: Results of the phase II KALLISTO trial. [Journal Article]
- EJEur J Haematol 2018 May 19
- CONCLUSIONS: In this small pilot study, combining low-dose deferasirox with erythropoietin did not improve erythroid response. It remains of interest to investigate early chelation approaches with even lower deferasirox doses plus erythropoietin in lower-risk MDS patients before the onset of transfusion dependence.
- Mini-Dose Glucagon as a Novel Approach to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes. [Journal Article]
- DCDiabetes Care 2018 May 18
- CONCLUSIONS: MDG may be more effective than insulin reduction for preventing exercise-induced hypoglycemia and may result in less postintervention hyperglycemia than ingestion of carbohydrate.
- A New Green Method for the Quantitative Analysis of Enrofloxacin by Fourier-Transform Infrared Spectroscopy. [Journal Article]
- JAJ AOAC Int 2018 May 18
- Background: A green analytical chemistry method was developed for quantification of enrofloxacin in tablets. The drug, a second-generation fluoroquinolone, was first introduced in veterinary medicin...
Background: A green analytical chemistry method was developed for quantification of enrofloxacin in tablets. The drug, a second-generation fluoroquinolone, was first introduced in veterinary medicine for the treatment of various bacterial species. Objective: This study proposed to develop, validate, and apply a reliable, low-cost, fast, and simple IR spectroscopy method for quantitative routine determination of enrofloxacin in tablets. Methods: The method was completely validated according to the International Conference on Harmonisation guidelines, showing accuracy, precision, selectivity, robustness, and linearity. Results: It was linear over the concentration range of 1.0-3.0 mg with correlation coefficients >0.9999 and LOD and LOQ of 0.12 and 0.36 mg, respectively. Conclusions: Now that this IR method has met performance qualifications, it can be adopted and applied for the analysis of enrofloxacin tablets for production process control. The validated method can also be utilized to quantify enrofloxacin in tablets and thus is an environmentally friendly alternative for the routine analysis of enrofloxacin in quality control. Highlights: A new green method for the quantitative analysis of enrofloxacin by Fourier-Transform Infrared spectroscopy was validated. It is a fast, clean and low-cost alternative for the evaluation of enrofloxacin tablets.
- Combined effect of Parathyroid hormone and Strontium ranelate on bone healing in ovariectomized rats. [Journal Article]
- ODOral Dis 2018 May 18
- CONCLUSIONS: PTH and SR combinations can be effective for calvarial bone regeneration of ovariectomized rats. PTH plus SR may have potential use as bone graft material in orthopaedic and dental surgery to enhance bone healing and osseointegration. This article is protected by copyright. All rights reserved.
- Optimization of orodispersible and conventional tablets using simplex lattice design: Relationship among excipients and banana extract. [Journal Article]
- CPCarbohydr Polym 2018 Aug 01; 193:89-98
- The objective of this study was focused on the optimization of the pharmaceutical excipients and banana extract in the preparation of orally disintegrating banana extract tablets (OD-BET) and convent...
The objective of this study was focused on the optimization of the pharmaceutical excipients and banana extract in the preparation of orally disintegrating banana extract tablets (OD-BET) and conventional banana extract tablets (CO-BET) using a simplex lattice design. Various ratios of banana extract (BE), dibasic calcium phosphate (DCP) and microcrystalline cellulose (MCC) were used to prepare banana extract tablets (BET). The results indicated that the optimal OD-BET and CO-BET consisted of BE: DCP: MCC at 10.0, 88.8, 1.2, 10.0, 83.8: and 6.2, respectively. AFM demonstrated that the surface of BET with BE + MCC was smooth and compacted when compared to BET with BE + DCP + MCC and BE + DCP. FTIR and XRD showed a correlation in the results and indicated that no interaction of each ingredient occurred in the process of BET formulation. Therefore, the experimental design is potentially useful in formulated OD-BET and CO-BET by using only one design simultaneously.
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- Health risk assessment of arsenic in Realgar and NiuHuangJieDu Tablets based on pharmacokinetic study. [Journal Article]
- JTJ Trace Elem Med Biol 2018; 48:81-86
- NiuHuangJieDu Tablets (NHJDT), a popular realgar (As4S4) containing patented traditional Chinese medicine (TCM), is widely used in the treatment of acute tonsillitis, pharyngitis, periodontitis and m...
NiuHuangJieDu Tablets (NHJDT), a popular realgar (As4S4) containing patented traditional Chinese medicine (TCM), is widely used in the treatment of acute tonsillitis, pharyngitis, periodontitis and mouth ulcer. However, arsenic is considered as one of the most toxic elements, leading to growing concerns about the quality and safety of realgar-containing TCMs recently. In this study, health risk assessment of arsenic in realgar and NHJDT was conducted through oral administration of both substances to rats with single and multiple doses, respectively. The total blood arsenic concentration was used as the health risk indicator and determined by hydride generation-atomic fluorescence spectrometry after modified Kjeldahl digestion, and then applied to the pharmacokinetic study. For single oral dose study in rats, the low, medium, and high doses of realgar and NHJDT were set equivalent to 1, 5 and 20 times the human therapeutic dose (1.3 mg realgar/kg), respectively. Multiple doses were given at low and high dose levels every 12 h for seven consecutive days, respectively. Significant differences in the total blood arsenic pharmacokinetic profiles were observed between the corresponding realgar and NHJDT groups. These results indicated that NHJDT significantly reduced the total blood arsenic exposure present in realgar, and the detoxification mechanism might be attributed to herb-herb interactions in NHJDT. However, the accumulation of blood total arsenic was significant due to the long elimination half-life and high accumulation index in both realgar and NHJDT groups. Therefore, the potential health risk of arsenic caused by the administration of realgar-containing TCMs should be taken into account for excessive or long-term medication. Precautions should be taken for the clinical application of realgar-containing TCMs.