• Journal of Pharmaceutical Investigation
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• v.34 no.4
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• pp.333-340
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• 2004

A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.529-540
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• 2004

After new medical system of separation of dispensary from medical practice was started in 2000 in Korea, to expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper, we examined the US guideline published in 1995 and compared with the Japanese guideline, which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.

• Biomolecules & Therapeutics
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• v.4 no.4
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• pp.411-414
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• 1996

Single subcutaneous administration to S.D rats of both sexes was performed to investigate the acute toxicity of Syndella gel, a new topical drug containing deproteinised dialysate of calf's blood and micronomicin sulfate. $LD_{50}$ values for S. D rats were 23,047 mg/kg for male and 23,725 mg/kg for female. The death occurred within 24 hours after administration at doses over 19,200 mg/kg. The main cause of death seemed to be respiratory disturbance by acute shock. Major general symptoms induced by injection subcutaneously with Syndella gel were underactivity, decreased respiratory rate, salivation, tremor and loss of consciousness. No significant body weight changes and gross findings of internal organs in treatment groups in comparison with those of control groups was observed at any dose levels in Syndella gel.

• Journal of Dental Anesthesia and Pain Medicine
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• v.16 no.4
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• pp.237-244
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• 2016

Topical anesthetics act on the peripheral nerves and reduce the sensation of pain at the site of application. In dentistry, they are used to control local pain caused by needling, placement of orthodontic bands, the vomiting reflex, oral mucositis, and rubber-dam clamp placement. Traditional topical anesthetics contain lidocaine or benzocaine as active ingredients and are used in the form of solutions, creams, gels, and sprays. Eutectic mixtures of local anesthesia cream, a mixture of various topical anesthetics, has been reported to be more potent than other anesthetics. Recently, new products with modified ingredients and application methods have been introduced into the market. These products may be used for mild pain during periodontal treatment, such as scaling. Dentists should be aware that topical anesthetics, although rare, might induce allergic reactions or side effects as a result of an overdose. Topical anesthetics are useful aids during dental treatment, as they reduce dental phobia, especially in children, by mitigating discomfort and pain.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.1
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• pp.29-37
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• 2020

Background: This study evaluated the efficacy of three intraoral topical anesthetics in reducing the injection needle prick pain from local anesthetic among children aged 7-11 years old. Methods: It is a prospective, Interventional, parallel design, single-blind, randomized clinical trial in which subjects (n=90) aged 7-11 years were included in the study based on an inclusion criteria. Subjects were divided into three groups based on computer-generated randomization with an allocation ratio of 1:1:1. Groups A, B, and C received benzocaine 20% jelly (Mucopain gel, ICPA health products Ltd, Ankleshwar, India), cetacaine anesthetic liquid (Cetylite Industries, Inc, Pennsauken, NJ), and EMLA cream (2% AstraZeneca UK Ltd, Luton, UK), respectively, according to manufacturer's instructions, for 1 minute prior to local anesthetic injection. After application of topical anesthetic agent, for all the groups, baseline pre-operative (prior to topical anesthetic administration) and post-operative scores (after local anesthetic administration) of pulse rate was recorded using Pulse oximeter (Gibson, Fingertip Pulse Oximeter, MD300C29, Beijing Choice Electronic). Peri-operative (i.e., during the administration of local anesthesia) scores were recorded using Face, Legs, Activity, Cry, Consolability (FLACC) Scale, Modified Children hospital of Eastern Ontario Pain Scale (CPS) behavior rating scale, and Faces Pain Scale (FPS-R) - Revised (For self-reported pain). Direct self-reported and physiological measures were ascertained using FPS-R - Revised and Pulse oximeter, respectively, whereas CPS and FLACC scales assessed behavioral measures. To test the mean difference between the three groups, a one way ANOVA with post hoc tests was used. For statistical significance, a two-tailed probability value of P < 0.05 was considered as significant. Results: The Cetacaine group had significantly lower pain scores for self-report (P < 0.001), behavioral, and physiological measures (P < 0.001) than the other two groups. However, there was no significant difference between the Benzocaine group and EMLA group during palatal injection prick. Conclusion: Cetacaine can be considered as an effective topical anesthetic agent compared to benzocaine 20% jelly (Mucopain gel) and EMLA cream.

• Journal of Veterinary Clinics
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• v.19 no.2
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• pp.260-263
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• 2002

Twenty-nine dogs with chronic keratoconjunctivitis sicca (KCS) were treated by topical administration of a petrolatum based 2% cyclosporine ointment twice daily. Causes and durations of KCS varied. Tear production increased in 25 of 32 eyes and clinical improvement in corneal health was noticed in 35 of 47 eyes. No serious adverse reactions were observed and only mild irritation was noticed by the owners immediately after the application of the ointment in some cases .

• Journal of Ginseng Research
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• v.13 no.2
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• pp.248-253
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• 1989

The effects of 13-cis-retinoic acid and ginseng saponin iron Korean red ginseng on hyperkeratinization of guinea pig skin were investigated by means of enzymatic analysis and light microscopic observation. To induce hyperkeratinization, hexadevance It was topically applied to the dorsal skin of female guinea Pigs every other day for eight days and 13-cis- retinoic acid or ginseng saponin solution was administered orally or topically applied daily during the experimental period. As a result, both topical application of ginseng saponin and oral administration of 13-cis-retinoic acid showed prepentive effects on hyperkeratinization while topical application of 13-cis-retinoic acid inhibited normal epidermal cell proliferation and reduced epidermal enzyme activities such as LDH. ICD and GSPDH below the levels in a normal epidermis. It is suggested that topical application of ginseng saponin and oral administration of 13-cis-retinoic acid may have beneficial efforts against hyperkeratinization possibly by controlling epidermal proliferation and enzyme activities related to epidermal energy metabolism.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.29 no.4
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• pp.142-155
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• 2016

Objectives: The purpose of this study is to examine whether there is a significant efficacy difference on infant and young child atopic dermatitis patients treated with Korean Medicine Treatment through 6 months between topical steroid used group and non-steroid group. Methods: The degree of atopic dermatitis was measured by the Objective SCORAD Index (OSI) with photographs of patients. Detailed analysis of the OSI score was compared based on the use of topical steroid. Results: 1. There was not a significant difference between the topical steroid group and the non-steroid group in regards of gender, age and initial OSI score. 2. The non-steroid group's OSI score decreased significantly from 50.17 to 29.20. 3. The topical steroid group's OSI score decreased significantly from 54.21 to 34.95. 76.19% of the patients in the topical steroid group discontinued steroid use within the 6-month period. The average time of discontinuation since the beginning of treatment was 3.36 months. 4. The OSI Improvement rate comparison of topical steroid group with non-steroid group did not show a significant difference over a 3-month and 6-month period. 5. Distribution of severe cases decreased in Both topical steroid and non-steroid group after 6 month treatment. Conclusions: The OSI score of infant and young child atopic dermatitis patients in both topical steroid and non-steroid group was decreased significantly with Korean medicine treatment through 6 months. There was no significant difference between topical steroid group and non-steroid group in OSI improvements over a 3-month period and 6-month period.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.3
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• pp.119-127
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• 2020

This study was conducted to determine how precooling reduces the subjective reported pain and objective pain and to evaluate the effectiveness of precooling the injection site before administration of local anesthesia in children. Electronic databases (PubMed, Ovid SP, Cochrane Central Register of Controlled Trials) were searched for publications from 1980 to 2020. Studies were screened for titles and abstracts, followed by full-text evaluation of included reports. Six studies were included in this systematic review. The primary outcome evaluated was the pain perception or the subjective pain reported by the child receiving the injection. The secondary outcome evaluated was objective pain evaluated in each study. Among 5 studies that evaluated child reported pain scores on a visual analogue scale (VAS), 4 studies reported lower scores in the precooling group and one study reported a higher VAS score in the precooling group than in children treated with 20% benzocaine topical anesthesia. Among 6 studies that evaluated the pain reaction of children by Sound Eye Motor (SEM) score, 4 studies reported a lower SEM score in the precooling group, one study reported no significant difference between the precooling and control groups, and one study reported higher SEM scores in the precooling group than in children treated with 20% benzocaine topical anesthesia. Within the limits of this systematic review, evidence suggests that precooling the injection site with ice can be an effective adjunct to topical anesthesia in reducing both subjective and objective pain during local anesthesia administration in children.

• Journal of Oral Medicine and Pain
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• v.40 no.1
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• pp.10-16
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• 2015

Purpose: Pilocarpine has the effects on improvement of salivary flow and subjective symptoms for xerostomic patients. Because of unwanted side effects following its systemic administration, topical pilocarpine has been paid attention as an alternative. This study aimed to investigate effects of pilocarpine solution as mouthwash on salivary flow and adverse effects compared to systemic administration of 5 mg pilocarpine tablet in healthy subjects. Methods: The study was a double blind, placebo-controlled, crossover clinical trial. Five milligrams pilocarpine tablets, 4 mL of 2% pilocarpine solution and placebo solution were given to 12 healthy volunteers (6 males and 6 females) in a predetermined order with wash-out period of at least two days and unstimulated whole saliva was collected before and after administration of each drug. Blood pressure and pulse rate was also measured and subjective effect and potential side effects were evaluated by a self-administrated questionnaire. Results: Systemic (5 mg tablet) and topical (2% solution) use of pilocarpine significantly increased salivary flow rate in healthy subjects compared to placebo (p<0.001). In both the pilocarpine solution and tablet groups, salivary flow rates at 120 minutes after administration remained increased. Subjective effect on salivation was the largest in the pilocarpine tablet group, followed by the pilocarpine solution group (p<0.05). There was no significant difference in blood pressure and pulse rate after administration of all three drugs. Fewer side effects reported in the pilocarpine solution group than in the tablet group. Conclusions: Two percents pilocarpine solution as mouthwash increases salivary flow rate, definitely superior to placebo solution and comparable to pilocarpine tablet, with fewer side effects in healthy subjects. It indicates a possibility of pilocarpine solution as a useful alternative of pilocarpine tablets for the xerostomic patients with systemic diseases.