• Archives of Pharmacal Research
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• v.28 no.4
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• pp.493-501
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• 2005

Effect of solvents on physical characteristics and release characteristics of monolithic acetaminophen (APAP) hydroxypropylmethylcellulose (HPMC) matrix granules and tablets were examined. Various types and amounts of solvents were employed for granulation and coating. APAP and other excipients were mixed and were then wet-granulated in a high-speed mixer. The dried granules were then directly compressed and film-coated with low viscosity grade HPMC. As the amount of water increased, the size of granules also increased, showing more spherical and regular shape. However, manufacturing problems such as capping and lamination in tableting occurred when water was used alone as a granulating solvent. The physical properties of HPMC matrix granules were not affected by the batch size. The initial release rate as well as the amount of APAP dissolved had a tendency to decrease as the water level increased. Addition of nonaqueous solvent like ethanol to water resulted in good physical properties of granules. When compared to water/ethanol as a coating solvent, the release rate of film-coated HPMC matrix tablets was more sensitive to the conditions of coating and drying in methylene chloride/ethanol. Most of all, monolithic HPMC matrix tablet when granulated in ethanol/water showed dual release with about $50\%$ drug release immediately within few minutes followed by extended release. It was evident that the type and amount of solvents (mainly water and ethanol) were very important for wet granulation and film-coating of monolithic HPMC matrix tablet, because the plastic deforming and fragmenting properties of material were changed by the different strengths of the different solvents.

• Proceedings of the Korean Society of Near Infrared Spectroscopy Conference
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• 2001.06a
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• pp.4114-4114
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• 2001

For the quality control of tablets several parameters have to be checked. The most important one is the content of an active ingredient which has to match a narrow range around the designated content. The only useful measurement mode is transmission which provides information of the complete tablet. A measurement in diffuse reflectance would register only the surface which is useless especially in case of a coated tablet. In this work tablets for a clinical study (placebo/verum studies) with very low concentrations of the active ingredient were measured. The concentration range was 0 to 6 mg with a total weight of the tablets of 105 mg, leading to a highest concentration of the active component of 5.7% by weight. Especially the spectroscopic distinction between the placebo and the low dosage forms with 0.25 and 0.5 mg active agent requires an extraordinarily accurate sampling technique. Using the VECTOR 22/N-T in transmission mode allows the collection of the information from the complete tablets. A quantitative PLS-model with transmission spectra from the tablets described above shows that the active substance can be predicted with a RMSECV (root mean square error of cross validation) of 0.04% absolute for this special application. The results are compared with those of measurements in diffuse reflectance using different accessories.

• YAKHAK HOEJI
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• v.41 no.1
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• pp.48-59
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• 1997

Sustained release matrix tablets, pellets, and coated pellets for the delivery of sulindac were prepared using cellulose derivatives at various ratios, and evaluated for the dis solution pattern. The release of sulindac, from matrix tablets prepared with low viscosity HPMC was relatively fast, and especially the tablets made of Metolose SM released all of sulindac within 1 hr. The release of drug from tablets made of other HPMC derivatives were retarded in the order of the following: Pharmacoat 645>Pharmacoat 606>Pharrnacoat 606+HPC-L>HPC-L. The most sustained release pattern was observed with the preparation of high viscous polymer. Metolose 90 SH. While release of sulindac, from matrix type pellet containing 10mg/cap of Metolose 90 SH or 60 SH was completed within 1 hr, a prolonged release formulation (30% in 1 hr) was obtained by the inclusion of EC. Pellets coated with HPMC showed a fast release pattern (${\geq}$ 80% within 2 hrs), whereas pellets coated with HPMC and EC (molar ratio 1 : 1) showed a sustained release pattern (${\geq}$ 80% in 12 hrs), vath the release from EC pellets being the most sustained. Fast (naked) and slow release pellets coated with EC, Metolose 60SH 50cps and propylene glycol. and enteric pellets coated with HPMCP 55 and Myvacet$^{\circledR}$ were prepared, and combined at various ratios for the assessment of dissolution pattern. The result indicates the possibility that the development of 24 hr sustained release delivery systems containing sulindac for oral administration could be achieved by means of combining sustained and fast release pellets at a proper portion.

• Journal of Pharmaceutical Investigation
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• v.41 no.2
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• pp.67-73
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• 2011

Ion exchange resins can be one of the good carriers for sustained drug release. However, the sustained release may not be enough only with themselves and hence film coating with rate controlling polymers can be applied to have a further effect on the drug release. Due to the environmental and economic issues of organic solvent for the polymer coating, aqueous polymeric systems were selected to develop dosage forms. Among the many aqueous polymeric dispersions for the film coating, EC (ethylcellulose) based polymers such as Aquacoat$^{(R)}$ ECD and Surelease$^{(R)}$ were evaluated.A fluid-bed coating was applied as a processing method. The drug release rate was quite dependent on the coating level so the release rate could be modified easily by changing different levels of the coating. The drug release rate in the Aquacoat$^{(R)}$ coated resin particles was strongly dependent on curing, which is a thermal treatment to make homogeneous films and circumvent drug release changes during storage. After dissolution test using the compressed tablets in which the coated resin particles are contained, inhomogeneous coating and even pores could be observed showing that the mechanical properties of EC were not resistant to granulation and compaction process. However, when tablets were prepared in different batches, the release profiles were almost identical showing the feasibility of the coated resin particle as incorporated into the tablet formulation.

• The Korean Journal of Pharmacology
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• v.13 no.1 s.21
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• pp.1-6
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• 1977

The physicochemical equivalencies of drugs are not usually correlate to the generic equivalencies of drugs and the generic equivalencies of drugs produced by different manufacturers or different formulations are being called in question frequently. The bioabailability of two formulations of oxytetracycline and erythromycin stearate were performed in healthy human volunteers. At the same time, the disintegration testes were performed with randomly sampled materials in question. For the biological evaluation of new oxytetracycline formulation; tablet(250mg), two-way cross over study in 10 healthy young volunteers was performed using oxytetracycline capsule (250mg) as reference, Erythromycin stearate (250mg) tablets and capsules produced by different manufacturers were compared in a two-way cross over study in 12 subjects with same manner of oxytetracyclines. oxytetracycline tablets showed somewhat slow disintegration rate, but appeared not statistical differences in serum concentrations from the reference, up to six hours after ingestion. Erythromycin stearate capsules disintegrated more rapidly than enteric coated tablets. Serum concentrations of capsules were more variable and markedly lower (P<.005 after 2hrs) than the enteric coated tablets. Rapid disintegration of capsules may result in destruction of active chemicals owing to the interaction with gastric acid and the above factor may contribute mainly to the low serum level after ingestion of capsules.

• Analytical Science and Technology
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• v.37 no.2
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• pp.114-122
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• 2024

A transmission Raman spectroscopy-based quantitative model, which can analyze the content of a drug product containing naproxen sodium as its active pharmaceutical ingredient (API), was developed. Compared with the existing analytical method, i.e., high-performance liquid chromatography (HPLC), Raman spectroscopy exhibits high test efficiency owing to its shorter sample pre-treatment and measurement time. Raman spectroscopy is environmentally friendly since samples can be tested rapidly via a nondestructive method without sample preparation using solvent. Through this analysis method, rapid on-site analysis was possible and it could prevent the production of defective tablets with potency problems. The developed method was applied to the assays of the naproxen sodium of coated tablets that were manufactured in commercial scale and the content of naproxen sodium was accurately predicted by Raman spectroscopy and compared with the reference analytical method such as HPLC. The method validation of the new approach was also performed. Further, the specificity, linearity, accuracy, precision, and robustness tests were conducted, and all the results were within the criteria. The standard error of cross-validation and standard error of prediction values were determined as 0.949 % and 0.724 %, respectively.

• Journal of Pharmaceutical Investigation
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• v.20 no.3
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• pp.51-76
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• 1990

It is sometimes said lately that the pH of the human gastric juice is significantly different among individuals. Thus, the dissolution behavior of coated solid dosage forms should preferably be independent of the pH of the test solution. With these points as a background, the effect of pH on the dissolution velocity of coated tablets was studied to compare that of Pharmacoat with other gastric soluble film coating materials. Three viscosity types of Pharmacoat have been available(3, 6 and 15cP) until now. the 6cP type has been considered to be the most suitable for a tablet coating amongst the three types. The 3 cP type with a low degree of polymerization, is capable of providing high concentration, but the film strength is so inferior that sometimes cracking of the film may occur. On the other hand, in the case of the 15cP type, high polymer concentration cannot be achieved because of the high dgree of polymerization, and thus it is uneconomical for coating. Now, there is a strong demand to reduce the coating time even when HPMC is used in the 6cP type in order to reduce the coating cost. In order to improve this problem, we have concentrated our attention on reducing the viscosity value of HPMC to an allowable lower limit from 6cP. As a result of this study, it was found that the reduction of the viscosity value to around 4.5cP enabled the use of a higher solution concentration and an incidental shorter coating time without giving any substantial adverse effects on the properties of coated preparations. These experiment results are presented in the later part of this presentation. Based on this study, we have added the viscosity type of 4.5cP as one of the Pharmacoat products as Pharmacoat-645.

• YAKHAK HOEJI
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• v.38 no.1
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• pp.38-45
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• 1994

An analytical method using capillary electrophoresis (CE) was developed for quantitation of water soluble vitamin contents in various vitamin products. The method includes the optimization of separation of 11 water soluble vitamins changing the micellar concentration and pH of running buffer, applied voltage and sample preparation. Best resolution was obtained with 25 mM phosphate buffer (pH=8.0) containing 50 mM sodium dodecyl sulphate (SDS) as micellar phase. At optimum condition, water soluble vitamins were determined in orange juice and vitamin products such as vitamin C pulvis, vitamin injection, coated multivitamin tablet. The quantitative analysis of water soluble vitamins with CE was suitable for quality control of pharmaceutical products with sound reproducibility.

• YAKHAK HOEJI
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• v.38 no.3
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• pp.250-264
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• 1994

Omeprazole(OMZ)-cholestyramine(CHL) and various OMZ-Dowex resin complexes were prepared by reaction between OMZ and activated resins in 0.1N NaOH solution. And their physical properties were tested by means of infrared(IR), differential scaning caloimeter(DSC), X-ray diffraction. Chemical stability of OMZ-CHL was increased markedly compared with OMZ and the decomposition of OMZ-CHL followed the pseudo first-order kinetics and the rate constants were $2.743{\times}10^{-4}/day$ at $20^{\circ}C$, $7.83{\times}10^{-3}day^{-1}$ under 80% RH and $1.68{\times}10^{-2}day^{-1}$ under UV radiation, respectively. On the other hand, the rate constants of OMZ were $2.996{\times}10^{-4}day^{-1}$ at $20^{\circ}C$, $1.17{\times}10^{-2}day^{-1}$ under 85% RH, and $4.07{\times}10^{-2}day^{-1}$ under UV radiation, respectively. The rates of dissolution of OMZ-CHL bulk and OMZ-CHL tablet were 100% and more than 85% in 15 minutes, respectively, which were increased than OMZ base and OMZ-tablet. In the acute toxicological test, the value of oral $LD_{50}$(mouse) was 4.608 g/kg. OMZ-CHL was pelletized using lactose, polyethyle neglycol(PEG), D-sorbitol, Avicel PH 101, sodium laurylsulfate and polyvinylpyrrolidone(PVP) K-30, and enteric coated with HPMCP, Myvacet, acetone, ethanol and cetanol, of which dissolution rate was found to be more than 85% in 10 minutes. From the above results, it was found that OMZ-CHL is a useful means for development of new oral dosage forms of OMZ.

• Fashion & Textile Research Journal
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• v.14 no.6
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• pp.1018-1023
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• 2012

Smartphone is integrated into the daily lives of all types of people not even young generation. A touch screen display is a primary input device of a smart phone, a tablet computer, etc. While there are many tough technologies in existence, resistive and capacitive are dominant and currently lead the touch screen panel industry. And a capacitive touch screen panel widely used in smart phones is coated with a material that stores electrical charges. In this study, we tried to manufacture gloves produced with electro-conducting leather as a tool to operate a touch panel screen. Therefore, electrically conductive materials, Polyaniline(PANI), Poly(3,4-ethylenedioxythiophene) (PEDOT), and Carbon nanotubes (CNT) were applied to the surface of leather to be used as a touching operator for capacitive touch screen panel. The leather samples were treated by simple painting method; firstly, they were painted with aqueous solution containing each of the electrically conductive materials and then dried. This cycle was repeated three times. Consequently, the treated leather samples showed electrical conductivity and reasonable working performance to the capacitive touch screen. And, PANI showed the best performance and highest electrical conductivity, and then PEDOT and, CNT in decreasing order. This is because the solubilities of PANI and PEDOT show higher than dispersibility of CNT. Thus, the concentration of conducting polymers was greater than that of CNT in the treating solutions.