• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
• /
• v.21 no.2
• /
• pp.120-125
• /
• 2008

Objectives : Medication is important in treatment for children, but prescribing traditional herbal medicine for them is very difficult. The aim of this study was to evaluate the preference for new and traditional dosage form of Onchung-eum. Methods : A total of 24 children who visited Oriental Medical Center of Daegu Hanny University during one month since March 2008 were included in this study. They compared new dosage form of Onchung-eum with traditional thing and evaluated items such as taste, perfume, color, sensation of chewing and texture. Results : As a whole they prefered new dosage form more than traditional thing in a sensory test. And 13(54%) children choose new dosage form as the better one. Conclusions : Considering the above results, the new dosage form might be efficacious to be taken by children. Further studies in other methods and new dosage forms are needed to make prescribing it for children easily.

• Journal of Pharmaceutical Investigation
• /
• v.41 no.2
• /
• pp.103-109
• /
• 2011

The objective of the study was to prepare self-microeulsifying drug delivery system (SMEDDS) incorporating atorvastatin calcium and evaluate its properties and oral bioavailability. Solubility of atorvastatin in various vehicles was determined. Pseudo-ternary phase diagrams were constructed to identify the good self-emulsification region. The droplet size distributions of the resultant emulsions were determined by dynamic light scattering measurement. The mean droplet size of chosen formulation (20% ethyl oleate, 40% tween-80, 40% Carbitol$^{(R)}$) was $23.4{\pm}1.3$ nm. The SMEDDS incorporating atorvastatin calcium appeared to be associated with better performance in dissolution and pharmacokinetic studies, compared with raw atorvastatin calcium. In dissolution test, the release percentage of atorvastatin from SMEDDS mixture could rapidly reach more than 95% within 3 min. Oral $AUC_{0{\rightarrow}8hr}$ values in SD rats was $1994{\pm}335\;ng{\cdot}hr/mL$, which significantly increased (P<0.05) compared with raw atorvastatin calcium. The SMEDDS formulation was relatively stable when stored at $4^{\circ}C$ during 3 months. Our studies illustrated the potential use of SMEDDS for the delivery of hydrophobic compounds, such as atorvastatin, by the oral route.

• Journal of Pharmaceutical Investigation
• /
• v.41 no.3
• /
• pp.191-196
• /
• 2011

In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{\pm}223.4$ $ng{\cdot}h{\cdot}mL^{-1}$, $177.4{\pm}34.2$ $ng{\cdot}mL^{-1}$, and $0.8{\pm}0.4$ and $3.5{\pm}2.1$, respectively, for the test formulations, and $640.7{\pm}186.6$ $ng{\cdot}h{\cdot}mL^{-1}$, $193.0{\pm}64.5$ $ng{\cdot}mL^{-1}$, and $0.9{\pm}0.4$ and $2.7{\pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.

• Journal of Pharmaceutical Investigation
• /
• v.37 no.2
• /
• pp.119-126
• /
• 2007

Tablet splitting is used in pharmacy practice to adjust the dose to be administered. However, it also causes several problems such as undesirable effect for sustained release or enteric-coated dosage form, inaccuracy of dose, and pharmacist's safety by splitting hazardous drugs. This study investigated the current status of oral dosage form splitting for patients older than 19 years by analyzing Korea National Health Insurance Claims Database. Out of oral solid drugs prescribed (N=1,486,584) 9.8% of them included tablets (or capsules) split. There were some splitting cases even in sustained release (4.9%), enteric-coated forms (1.3%) and hazardous drugs (2.7%) that were selected by NIOSH (The National Institute for Occupational Safety and Health). The most frequently split drugs were antihistamines, neuropsychotics and steroids. In case of digoxin and warfarin, unit doses in a domestic market were not diverse compared to foreign markets. Guidelines for splitting oral solid dosage forms, approval of diverse doses and conducting dose-response studies for the commonly splitting ingredients on Korean people are needed for the saff and effective use of oral solid drugs.

• Journal of Pharmaceutical Investigation
• /
• v.40 no.5
• /
• pp.313-319
• /
• 2010

The objectives of this study were to evaluate the effect of formulation ingredients on the drug release and to optimize the novel sustained release matrix tablet formulations of bupropion hydrochloride. A three factor, three-level Box-Behnken design was used for the optimization procedure, with the amounts of PEO ($X_1$), citric acid ($X_2$) and Compritol 888 ATO ($X_3$) as the independent variables. The selected dependent variables were the cumulative percentage values of bupropion hydrochloride that had dissolved after 1, 4 and 8 hr. Various dissolution profiles of the drug from sustained release matrix tablets were obtained. Optimization was performed for $X_1$, $X_2$ and $X_3$ using the following target ranges; $30%{\leq}Y_1{\leq}45%$; $70{\leq}Y_2{\leq}85%$; $85%{\leq}Y_3{\leq}100%$. The optimized formulation for bupropion hydrochloride was achieved with 12.5% PEO ($X_1$), 2.5% citric acid ($X_2$) and 10% Compritol 888 ATO ($X_3$). The sustained release matrix tablets with the optimized formulation provided a release profile that was close to predicted values. In addition, the dissolution profiles of the sustained release matrix tablet with the optimized formulation were similar to those of the commercial product Wellbutrin$^{(R)}$ SR tablets ($f_2$=79.83).

• YAKHAK HOEJI
• /
• v.16 no.3
• /
• pp.113-120
• /
• 1972

The last decade of this centry is now the accepted birth date of that sub-discipline of pharmacy that is now called 'biopharmceutics'. Wagner defines biopharmaceutics 'as the study of the influence of fomulation on the therapeutic activity of a drug product.' More specifically, he states that biopharmaceutics encompasses the study of the relationship between the nature and intensity of the biological effects observed in animals or man and the following factors: 1. The nature of the form of the drug (ester, salt, complex, etc). 2. The physical state, particle size, and surface area. 3. Presence or absence of adjuvants with the drug. 4. The type of dosage form in which the drug is administered. 5. The pharmaceutical process (es) used to make the dosage form. The philosophy inherent in this definition has revolutionized our thinking with respect to product development, quality control, and to the practice of pharmacy itself. Althoughthe the emphasis herein will be on quality control, the interrelationship between this and the other areas of pharmacy will be evident. The principles of quality control dictate that a wide variety of techniques be used to evaluate the quality of a dosage form. Since quality must be built into a dosage form, the pharmaceutical scientist begins the process at the research stage, continues it during the production stage, and ends it by applying the tests and procedures established by parmacopeial commissions. These stages are usually separate and distinct and, because of this, product quality has become synonymous with compliance with pharmacopeial specifications.

• 대한상한금궤의학회지
• /
• v.5 no.1
• /
• pp.101-111
• /
• 2013

Objective : The purpose of this study is to find out the proper dosage of Ma-huang for clinical use of Shanghanlun(傷寒論) Methods : To achive the purpose of this study, web-databases(pubmed, naver, google) were searched with the keywords including 'dose of Ma-huang Ephedra Ephedrine','dosage of Ma-huang Ephedra Ephedrine', and 'water extract of Ma-huang Ephedra'. The searched 30 papers and articles were reviewed. Results & Conclusions : 1. Proper dosage of Ma-huang 1) Adult: up to 9-12g/day 2) Adolescent: up to 6g/day 3) Hypertension disorder patient: up to 6g/day 4) lactating women: up to 6g/day 5) child: <2 years 0.7-2.5g/day, $${\geq_-}2$$ years 2.6-6g/day (Different from body weight) Although administration of Ma-huang to hypertension disorder patient, lactating women, child is safe on the paper, It is not recommended to these people because Ma-huang is one of toxic herbs. 2. Dosage form of Ma-huang There's no safety paper about pill or powdered Ma-huang(麻黃). There's not pill or powdered prescription of Ma-hunag in Shanghanlun(傷寒論), either. So it is recommended to administrate water exetract of Ma-huang.

• YAKHAK HOEJI
• /
• v.59 no.2
• /
• pp.70-76
• /
• 2015

A Softgel is an oral dosage form for medicine similar to capsules and softgel dosage form offers several advantages over other oral dosage forms, such as delivering a liquid matrix designed to solubilize and improve the oral bioavailability of a poorly soluble compound as a unit dose solid dosage form, delivering low and ultra-low doses of a compound. This study aimed to qualify a proprietary vegetable soft capsule which contains modified starch and carrageenan as capsule shell components compare to the conventional gelatin softgel. Four kinds of samples were prepared with vegetable and gelatin capsule shell, respectively. Morphology of capsule shell, mechanical strength of capsule, and hygroscopic properties were studied for comparing the quality attributes of softgel. Short-term stability against heat and moisture was also investigated in this study. Vegetable capsule shell showed better mechanical strength, physical stability and disintegration time for temperature and humidity than those of conventional gelatin capsule shell with four different filling materials used frequently as soft capsule form. Conclusively, this vegetable capsule shell polymer system can replace easily gelatin-shell systems and additionally allows encapsulation of lipid fills at high temperatures that are semisolid or solid-like at room temperature.

• Journal of Pharmaceutical Investigation
• /
• v.29 no.2
• /
• pp.127-136
• /
• 1999

In order to eliminate demerits of conventional dosage forms, dipotassium glycyrrhizate was formulated as a slim mucoadhesive film type dosage form. The mucoadhesive drug layer gel containing dipotassium glycyrrhizate was prepared using $Noveon^{\circledR}$ AA-1, hydroxypropylcellulose-M, ethylcellulose N 100 and citric acid, and the protective layer gel by using ethylcellulose N 100, $Eudragit^{\circledR}$ RS and castor oil. The viscosity of drug layer gel of mucoadhesive film was enhanced as the increased amount of $Noveon^{\circledR}$ AA-1 or hydroxypropyl cellulose-M. The drug content was unifonnly $1160{\pm}14.6\;{\mu}g$, and was varied within 3.5%. The optimum film dosage form showed a good fluidity and malleability of drug layer, with 179 g of thickness, pH 5.7, 411 min of in vitro adhesion time and 172 g in gravity adhesive strength. The release time of drug from the mucoadhesive film was significantly shorter but was delayed when polymers such as ethylcellulose was added. From these results, the new mucoadhesive film may be effective for the treatment of aphthous stomatitis.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
• /
• v.11 no.1
• /
• pp.197-218
• /
• 1998

In this study, I invastigate about oriental medical drug, dosage form and directions in external therapy of contact dermatitis. and after study on relationship oriental medical drug, dosage form and directions with cause, symptom and differentiation of symptom and sign. The results are as follows; 1. Most frequently used oriental medical drug is until qing(淸) dynasty Eriocheir sinensis H. Milne-Edwards(蟹), Salix babylonica L.(柳葉), Natrii sulfas(芒硝), Allium macrostemon Bge.(해), Nelumbo nucifera Gaertn.(荷葉), nowadays in Korea and China Phellodendron amurense Rupr.(黃柏), Gypsum(石膏), Rheum palmatum L.(大黃), Baphicacanthus cusia Bremek(靑黛), Talcum(滑石). 2. In the frequency of dosage form, until qing(淸) dynasty powder 1case, liquor 49cases, liquer and solid mixture 58cases, nowadays Korea and China powder 16cases, liquor 96cases, liquer and solid mixture 59cases. 3. Most frequently used directions of dosage is thinly attaching method(薄貼法), attaching method(敷貼法), furnigating and cleansing method(熏洗法), cleansing method(洗傷法), wet dressing method(濕敷法), spreading powder method(撲粉法), plaster method(途차法), rubbing skin method(摩擦法) 4. In the external therapy of contact dermatitis, oriental medical drug's usage is based on stage of contact dermatitis In acute stage, most frequently used drug is heat and damp remove drug(淸熱燥濕藥), nature of drug(藥性) is bitter taste and cold charactor(苦寒), In chronic stage, most frequently used drug is nourishing the blood drug(養血藥), promoting blood circulation drug(活血藥). 5. The dosage form of drug is based on symptom. In acute stage, when papules and vesicles, or erosion and exudation is the main symptom of skin, liquor or powder is used, when erosion and crust is the main symptom of skin, plaster is used. In chronic stage, plaster is used. 6. In the directions of dosage is based on dosage form of drug and symptom. In acute stage, when papules and vesicles is the main symptom of skin, fumigating and cleansing method, cleansing method, plaster method is used, when erosion, vesicles and exudation the main symptom of skill, cleansing method, wet dressing method, spreading powder method, attaching method, spreading powder method is used, when crust is the main symptom of skin, plaster method is used. In chronic stage, plaster method, rubbing skin method is used.