Warpage optimization and influence factors analysis of 3D printing personalized JJY tablets.

To explore the feasibility of preparing traditional Chinese medicine using 3 D printing technology and reduce warpage commonly occurs in large-size tablets, we investigated the prescription, warpage optimization and influence factors of 3 D printing Jiuxiang Jianpi Yangwei (JJY) tablets. The procedures used conformed to the requirements of the 2015 edition of the Chinese Pharmacopeia. The results of the prescription screening showed that 75% ethanol and HPMC (9%) could be adhesives. Meanwhile, stevia (0.5%) and citric acid (0.5%) improved the taste of the 3 D printed JJY tablets. To ensure the quality and appearance of the printed tablets, the best parameters were as follows: drying at room temperature, 40% of the filling density, a 3 mm model height, two outer ring numbers and a printing speed of 15 mm/s. The optimized printed tablets had a smooth appearance, suitable hardness, with the weight uniformity in accordance with the Pharmacopeia. We also prepared personalized JJY cartoon tablets (which contained images of a big-headed pig and a small yellow duck) which were designed to increase the compliance of children when taking their medications. In conclusion, this study reported that 3 D printing technology has great potential for preparing traditional Chinese medicines, and it provided guidance for 3 D printing tablets without warpage.

Quantitative fingerprint and quality control analysis of Compound Liquorice Tablet combined with antioxidant activities and chemometrics methods.

BACKGROUND: Herbal medicine (HM), as a complex system, is difficult to investigate their quality consistency effectively by chromatographic fingerprinting obtained in a single detection method. Moreover, active compound discovery affords no information about pharmacological activity until late in the discovery process, and the interaction between HMs in vitro is not yet clear, which requires sufficient practice to prove their effectiveness. PURPOSE: Therefore, the purpose of this study was to improve the quality control methods of Compound Liquorice Tablet (CLT) using multi-wavelength fusion fingerprinting, explore the possible antioxidant components and assess the interaction between herbs combined with bioactivity evaluation. METHODS AND DESIGN: Once the theoretical standard preparation obtained in combination of multi-wavelength fusion fingerprinting and hierarchical clustering analysis, averagely linear quantified fingerprint method could rapidly calculate the composition similarities and efficiently quantify the multiple components of CLTs without any chemical standard. Furthermore, the fingerprint-efficacy relationship was investigated by integrating high performance liquid chromatography fingerprints with antioxidant activity assessment using the partial least squares model, which was capable of directly discovering the bioactive ingredients. Hereafter, combination index value was introduced to evaluate the correlation between the two antioxidant herbs in CLT formula. RESULTS: The results showed that CLT samples were effectively identified and quantified, and their quality was accurately distinguished. By analyzing the antioxidant evaluation results, it was found that CLT had strong antioxidant activity, and through the study on PLS model and antioxidant activity assay of individual compounds, it was found that the order of chemical constituents responsible for antioxidant activity in CLT was as follows: flavonoids > saponins > alkaloids. Finally, it was determined that the CI value of GE-PPCE was in the range of 1.20-1.61, indicating that the interaction of the GE-PPCE pair was a slight antagonism. CONCLUSION: Thus, this study provided a preferred way for monitoring the quality consistency of HM, exploring possible bioactive components of HMs and assessing the interaction between herbs.

A Novel Forming Method of Traditional Chinese Medicine Dispersible Tablets to Achieve Rapid Disintegration Based on the Powder Modification Principle.

Slow disintegration and poor solubility are common problems facing the dispersible tablets of Traditional Chinese Medicine (TCM). In an early study, the research group found that co-grinding of extracts and silica could achieve a rapid disintegration effect, though the mechanism of this effect was not thoroughly elucidated. In this study, Yuanhu Zhitong dispersible tablets (YZDT) were selected as a model drug to explore the mechanism of rapid disintegration and dissolution. First, eight types of silica were used to prepare modified YZDT, and their disintegration time and amount of dissolution within 5 min were measured. Next, the powder properties of eight types of silica were investigated. By correlation analysis, it was found that the average pore size and density of silica were closely related to the effect of promoting disintegration. It was determined that the co-grinding of silica and extracts provided high porosity for the raw material drug, and its abundant narrow channels provided a strong static pressure for water penetration to achieve a rapid disintegration effect. Meanwhile, it was found that the addition of silica had a certain effect on promoting dissolution. Our results provide a highly operational approach for improving the disintegration and dissolution of TCM dispersible tablets. Meanwhile, this approach is also beneficial for establishing a high-quality evaluation index for silica.

Physicochemical quality profiles of commercial oral tablets and capsules containing lutein - impact of insufficient specific sanitary regulations.

Dietary supplements in many countries such as the USA do not require registration prior to commercialization. The Agência Nacional de Vigilância Sanitária (ANVISA) registers substances with functional properties as foods. Lutein is a carotenoid with antioxidant activity available on the market. However, no regulatory mandates exist to govern the design of quality control tests, which are necessary to ensure formulation effectiveness. Therefore, in the present study, tablet and dosage formulations from different manufacturers were tested following general methods outlined in the Brazilian and American Pharmacopeias. The averageweight, disintegration, content and dose uniformity assays were performed for all tablets and capsules, whereas hardness assays were only performed on tablets. None of the 10 formulations studied were found to be of satisfactory quality. Of all tablets tested, two had no-significant available lutein content, which may indicate adulteration. The capsules displayed adequate amounts of lutein, however had alarmingly negative disintegration and dissolution test results, which may contribute to non-bioavailability of lutein. All formulations analyzed are currently being marketed in the Brazilian and American markets. The low physicochemical performance in these formulations can be explained by the lack of specific regulations, which are necessary to ensure the quality of lutein-containing products on the market.

Dissolution and uniformity of content of tablets developed with extract of Ximenia americana L.

Herbal medicines currently represent an important part of the world pharmaceutical market, which shows growing interest in the use of herbal medicines. However, the production of such medicines involves a complex series of steps, which determine the production viability and the quality of the final product. Ximenia americana L. is a plant occurring in several regions of the world, with well-known and applied medicinal properties. Thus, the aim of this work was to develop and evaluate the physical and physical-chemical quality of tablets produced with X. americana L. extract. The extract was spray-dried from a hydroethanolic extractive solution and characterized as to its phytochemical composition. The chemical marker was determined and quantified using validated chromatographic methods. These methods indicated the presence of gallic acid at a concentration of 1.61 mg g(-1). Formulations were proposed and analyzed for their flow and compaction properties. The best formulation was used to obtain a batch of tablets, which was evaluated for its quality characteristics and showed to be within the pharmacopoeial specifications for average weight, hardness, friability, and disintegration time. The dissolution profile of the tablets produced was obtained, showing the release of about 70% of the vegetable extract content within 30 minutes. Results showed that it was possible to obtain herbal tablets containing a high content of vegetal extract by direct compression, developing a rapid process of formulation and production and guaranteeing the quality characteristics of the final product.

Design development and evaluation of triphala tablets.

Triphala is a combination of three herbs amla, bahera and haritaki, it is widely available in the form churna and is a valued formula since ancient times. The aim of this research was to develop reproducible batches of triphala tablets and evaluation of the optimized batch. Direct compression was the method of choice. The tablets were prepared using different directly compressible excipients MicroceLac, Ludipress, Ludiflash. High Performance Liquid Chromatography (HPLC) method was employed for authentification of the herbs using gallic acid as the marker. The tablets were evaluated as per the pharmacopoeial tests. The tablets each weighing 600 mg were successfully formulated fulfilling the limits of evaluation.

"Take your pill": the role and fantasy of pills in modern medicine.

The pharmaceutical industry has undergone a vast expansion in the 20th and 21st centuries. This article explores the central role now played by pills in clinical practice, but also in the public imagination. First, this article analyzes four properties that, together, account for many of the promises and perils associated with pills: They are ingestible, potent, reproducible, and miniaturized. This allows them to serve as ideal consumer items for widespread distribution and sale and also as model technological "devices" capable of downloading into the body healing chemicals. As such, they seem to promise a disburdening solution to many of life's ills. In our cultural fantasy, often shared by physician and patient alike, pills can be used not only to treat and prevent disease but also raise energy, lose weight, lessen pain, lift mood, cope with stress, and enhance sexual and athletic performance. This article also explores many adverse effects not only of pills themselves but of this exaggerated cultural fantasy of the pill. It tends to distract us from other, more holistic understandings of the locus of disease and healing. It even fosters misunderstandings of the ways in which pills themselves work, which is to assist bodily processes, and the mind's "meaning response." The intent here is not to demonize all pills-many have great therapeutic potential-but to learn how to better choose and use them wisely. We propose that this process be assisted through recontextualizing the pill as a multidimensional gift. Taken in such a way, with appropriate gratitude and discernment, we may ingest fewer pills, but with greater efficacy.

Treatment of seasonal allergic rhinoconjunctivitis with a once-daily SQ-standardized grass allergy immunotherapy tablet.

OBJECTIVES: Specific immunotherapy with the grass allergy immunotherapy tablet (AIT) has been developed as an effective, well tolerated, and convenient treatment for grass pollen induced seasonal allergic rhinoconjunctivitis (ARC). Six phase II/III randomized, placebo-controlled trials with the duration of a single grass pollen season of treatment using the SQ-standardized grass AIT, Grazax (Phleum pratense, 75,000 SQ-T/2,800 BAU, ALK, Denmark), have been published previously. This review compares results from these trials. METHODS: As outcome measures and methods of assessing them were similar across the trials, we have summarized the main efficacy findings (Total Combined Score [TCS], average daily rhinoconjunctivitis symptom and medication scores, percentage of well days, quality of life scores) during a single season of treatment with grass AIT in adults and children with seasonal ARC. RESULTS: The results of the European and North American trials were similar. Compared with the placebo group, who received symptomatic medications only, treatment with grass AIT resulted in fewer rhinoconjunctivitis symptoms, a lower intake of symptomatic medication, better patient self-rated quality of life and a greater percentage of well days during the entire grass pollen season. The data indicate that grass AIT treatment is equally effective in adults and children; the measured effect varies with pollen exposure, but is comparable across regions and continents, with a consistent difference compared with placebo in TCS that was above 20% for all trials. Local adverse events were experienced by the majority of patients. These reactions were generally mild to moderate in severity and transient in duration. Systemic adverse events were rare. CONCLUSIONS: This review confirms SQ-standardized grass AIT as a suitable therapeutic option for seasonal use in patients aged 5 years or older with grass pollen induced ARC.

International harmonization of generic drugs: in vitro dissolution tests for Japanese and American generic tablets.

Ibuprofen tablets on the market in Japan and the USA were compared by manual- and automatic-dissolution tests according to USP24 criteria. Dissolution test were performed in 900 ml of phosphate buffer of pH 7.2 at 37.0+/-0.5 degrees C at 50 rpm for 60 min, and the time required for 70% dissolution (T70%) and 5% dissolution after 60 min (A60) were evaluated. The dissolution profiles of both Japanese and American tablets by the automatic-method showed almost the same profiles as those of the manual method. T70% of the American and Japanese tablets by the manual method were not significantly different (p>0.05) from the automatic-method at various sampling positions. The A60 of the American and Japanese tablets by the manual-method was not significantly different (p>0.05) except at one position. The results indicate that the automatic-method was more reproducible than the manual-method, and also that systematic error was negligible. The T70% and A60 of the American tablets were significantly different (p<0.05) from the Japanese tablets. The American tablets were a film-coated over-the-counter drug and the Japanese tablets were a sugar-coated prescription drug. There was a difference in dissolution behavior between the dosage forms of the two countries.

In-vitro evaluation of khaya and albizia gums as compression coatings for drug targeting to the colon.

Khaya and albizia gums were evaluated as compression coatings for target drug delivery to the colon using indometacin (a water insoluble drug) and paracetamol (a water soluble drug) as model drugs. The core tablets were compression-coated with 300 and 400 mg of 100% khaya gum, 100% albizia gum and a mixture of khaya and albizia gum (1:1). Drug release studies were carried out in 0.1(M) HCl (pH 1.2) for 2 h, Sorensen's buffer (pH 7.4) for 3 h and then in phosphate-buffered saline (pH 6.8) or in simulated colonic fluid for the rest of the experiment to mimic the physiological conditions from the mouth to colon. The results indicated that khaya and albizia gums were capable of protecting the core tablet in the physiological environment of the stomach and small intestine, with albizia gum showing greater ability than khaya gum. The release from tablets coated with the mixture of khaya and albizia gums was midway between the two individual gums, indicating that there was no interaction between the gums. Studies carried out using rat caecal matter in phosphate-buffered saline at pH 6.8 (simulated colonic fluid) showed that the gums were susceptible to degradation by the colonic bacterial enzymes, leading to release of the drug. The results demonstrate that khaya gum and albizia gum have potential for drug targeting to the colon.

The quality assessment of compound liquorice tablets by capillary electrophoresis fingerprints.

Capillary electrophoresis (CE) is a powerful separation technique that is peculiarly able to determine the fingerprints of traditional Chinese medicine. The Capillary Electrophoresis Fingerprints (CEFP) of compound liquorice tablets (CLTs) was established to evaluate the quality of CLTs. The background electrolyte was a 50 mM sodium borate solution. The detection wavelength was 228 nm and a 14 kV voltage was applied. Hydrochlorothiazide served as an internal standard and temperature was 24-25 degrees C. The CLTs were extracted by a 50 mM borate solution containing 10% (v/v) methanol. The results showed that CE was a powerful tool for detecting of the fingerprints of traditional Chinese medicine and their constituents. The quality assessments were performed to compare the correlation coefficients (R) and cos theta (C) between each batch vector of CLTs and the total standard profile vector (TSPV), which was the mean vector of all the batch vectors of CLTs with 1.0. The nearer to 1.0 was the R or C, the higher was the similarity. The values of R and C between the TSPV and each batch vector of CLTs produced at different factories were all above 0.9150. The values of R and C between every two standard profile vectors (SPV) from different factories were all above 0.9420. A good stability and reproducibility of the CEFP of CLTs were obtained in the study. Further, we first put forward a new parameter Q to evaluate both the quantification accuracy and the qualitative accuracy for a CEFP, which was verified by determinations of GHIA, GHEA, MP and SB in CLTs. The CEFP was successfully employed to assess the quality of CLTs produced at Kunming Pharmaceutical Factory to be good.

[Technology for tablets with herbal extracts and evaluation of its quality]. / Tableciu su augaliniais ekstraktais technologijos kurimas ir kokybes ivertinimas.

The article deals with the development of technology for production of tablets containing dry herbal extracts. Dry herbal extracts of two different compositions were produced by spray drying using BUCHI 190 apparatus. The quality of dry extracts was evaluated by determination the loss of extract mass during the drying process, and estimation of the amount of biologically active combinations. The tableting methods for dry herbal extracts--direct compression and also employing granulation--were used. The quality of the produced tablets was determined by examining their appearance, resistance to abrasion, crushing strength, mass uniformity, disintegration time. Contents of biologically active compounds in tablets were evaluated by the quantitative methods.

Estabilidad acelerada de tabletas de levodopa-carbidopa (250-25 mg) / Quick stability of levodopa-carbidopa pills (250-25 mg)

Se realizó el estudio de estabilidad acelerada de tabletas de levodopa-carbidopa (250-25 mg) con el empleo de un método de cromatografía líquida de alta resolución y se comprobó su especificidad para estos fines. Se analizó la influencia de medios degradantes artificiales sobre los productos activos, además del efecto de la humedad sobre la estabilidad del producto, colocándolo en hidrostatos con humedades controladas. Este medicamento, producción nacional, cumplió con las especificaciones de calidad descritas en la USP 23 y mostró una alta estabilidad térmica(AU)