1.Comparison of efficacy and safety of Vitex negundo 600 mg (Ascof® Forte) capsules with Vitex negundo 600 mg (Ascof® Forte) tablets in the treatment of acute uncomplicated cough among Filipino adults in Cavite
Rita Grace Y. Alvero ; Josefino R. Alvero ; Geraldo P. Balaccua
Acta Medica Philippina 2022;56(12):28-35
Objectives:
Vitex negundo is an endemic shrub in the Philippines which has been clinically tested for the symptomatic treatment of cough in syrup and tablet formats. However, the effectiveness and safety of the capsule have not been formally documented in a clinical trial setting. Therefore, in compliance with the Philippine FDA directive, this study compared the efficacy and safety of the capsule and tablet formats after three days of treatment among Filipinos with acute uncomplicated cough.
Methods:
This is a Phase 3b randomized, open-label, parallel-group non-inferiority study with 335 subjects using improvement based on Global Rating of Change Scale scores as primary efficacy endpoint and several secondary endpoints. Descriptive and inferential analyses were performed. The Farrington-Manning Method of Z-test with -10% non-inferiority margin was used for the primary outcome. Appropriate inferential tests were used for the secondary outcomes.
Results:
Of 335 enrolled subjects, 170 were randomized to the capsule group and 165 to the tablet group with comparable baseline characteristics. The proportion of success based on the Global Rating of Change Scale rated by patients was 95.71% and 91.19% for the capsule and tablet groups, respectively. Based on doctors’ ratings, they were 96.93% and 94.34%, respectively. In addition, the Farrington-Manning Method of Z-test revealed the capsule was not inferior to the tablet based on patients’ and doctors’ ratings (90% Confidence Intervals: -0.0086 to 0.0988 and -0.0228 to 0.0747, respectively). The intention-to-treat analysis also showed non-inferiority, indicating robust results. Significant and similar improvements in cough severity and quality of life were observed in both groups based on Cough Severity Diary scores and Leicester Cough Questionnaire for acute cough, respectively. There were also improvements in the Forced Expiratory Volume at 1 second [FEV1] (capsule group) and Peak Expiratory Flow Rate [PEFR] (both groups), but these were not clinically significant. The safety profiles were also comparable (p= 0.4437) with 1.23% and 2.52% incidence of adverse events, respectively, all of which were mild and assessed as not related to the drug.
Conclusion
In terms of efficacy, Ascof® Forte capsule was non-inferior to Ascof® Forte tablet in treating acute uncomplicated cough among Filipinos based on Global Rating of Change Scale scores as rated by patients and doctors. Both treatments showed significant and similar improvements in cough severity and quality of life. They were also comparable in safety with few adverse events in both groups, all mild and assessed unrelated to drug intake.
Capsules
2.Pilot study on manufacture of theophylline microcapsule by isolation method of congelation - phase
Pharmaceutical Journal 1999;282(10):23-24
Preparation of theophylline microcapsule by the coacervation - phase seperation method. Theophylline microcapsule has been prepared by coacervation - phase seperation, using ethyl cellulose as the coating material. Ethyl cellulose sustanined significally the release of theophylline from microcapsule. Microcapsule has been used for preparation of theophylline sustained - release tablet.
Theophylline
;
Capsules
3.Study on preparation of theophylline microcapsule by spray-drying method
Pharmaceutical Journal 1999;282(10):20-21
The theophylline microcapsule has been prepared by spray-drying technique, using ethyl cellulose as the coating material. Ethyl cellulose sustained significally the release of theophylline from microcapsule has been used for preparation of theophylline sustained-released tablet.
Theophylline
;
Capsules
4.Pilot assay of metromidazole micro gelules by methode separating lyophilisation phase from heating spray
Pharmaceutical Journal 2000;269(12):15-17
Microcapsules of metronidazole with ethyl cellulose have been prepared by coacervation technique and spray drying technique. The microcapsulated ratio of metronidazole was evaluated. Core: wall ratio and preparing method influenced significally on the release of metronidazole from microcapsules
Capsules
;
Pilot Projects
;
metronidazole
5.Study on manufacture of indomethacine Pellet LR by method of strengthening gradually
Pharmaceutical Journal 2004;44(6):21-23
The goal: Pellet was introduced into sustained release product containing indometacin to promote the advantage of this drug form. The material: Indometacin (China), avicel pH 101 (Taiwan), lactose (Holland), polyvinylpyrolidon (Holland), hydroxypropyl methylcellulose (England)… The method: Pellet indometacin was prepared by layering method. The result: the optimal formulary to prepare sustained release pellet indometacin using layering method was selected. Coated pellet may be filled into the capsules shell or compressed into tablet having sustained release effect by oral (up to 12h)
Indomethacin
;
Pharmaceutical Preparations
;
Capsules
6.Application and potential future directions of self-healing polymers in dentistry.
Xiao-Xi WANG ; Shuo YAO ; Chuan-Jian ZHOU ; Jun-Ling WU
West China Journal of Stomatology 2020;38(1):75-79
Self-healing materials have rapidly developed in recent years to overcome the micro-cracks occurring in the polymer matrix. Self-healing ability offers autonomous crack repairs to prolong the service lives of polymers or polymer composites. As a main approach, extrinsic self-healing materials based on microcapsules have been applied in dentistry recently. This paper comprehensively presented and reviewed the definition and classification of self-healing materials, the synthesis of microcapsules, the calculation of self-healing efficiency, and the application of self-healing materials in dentistry. The future directions of self-healing polymers are also discussed.
Capsules
;
Dentistry
;
Polymers
7.Lisfranc Joint Injury.
Journal of Korean Foot and Ankle Society 2016;20(3):106-111
The Lisfranc joint complex is an anatomical association of many bones and articulation, restrained by an even more complex network of ligaments, capsules, and fascia, which must work in concert to provide normal and painless motion. Careful diagnostic workup with high-quality radiographs and computed tomography of the foot are used to diagnose injuries and fractures of this complex. We have to understand the normal anatomy and injury mechanism in order to appropriately treat Lisfranc injuries. Good results have been associated with anatomic reductions of all bones, which was achieved with restoration of proper alignment.
Capsules
;
Fascia
;
Foot
;
Joints*
;
Ligaments
8.Dissolution test for some chloramphenicol capsule sample
Journal of Medical and Pharmaceutical Information 2003;10():10-33
This study was aimed to assess the dissolution of 4 chloramphenicol capsule products of 4 Vietnamese pharmaceutical enterprises. The results showed that most of them have a very low drug release degree. The cause may be resulted from making capsule without making particles, too raw powder, using too much insoluble excipient, too high rate of insoluble excipient. The dissolution test should be considered an item of chloramphenicol capsule specification
Chloramphenicol
;
Adjuvants, Pharmaceutic
;
Capsules
;
drugs
9.Contrast Enhancement Characteristics of Hepatocellular Carcinoma According to the Tomor Size on Two-Phase Scan with Spiral CT.
Jee Eun KIM ; Dal Mo YANG ; Myung Hwan YOON ; Seok CHUN ; Hyung Sik KIM ; Hyo Seon CHUNG ; Young Seok LEE
Journal of the Korean Radiological Society 1996;34(2):245-249
PURPOSE: To determine the enhancing patterns of hepatocellular carcinoma(HCC) and the difference of enhancing patterns according to the tumor size, using spiral CT. MATERIALS & METHODS: We reviewed 213 lesions in 76patients who had been clinically or histopathologically diagnosed as HCC sufferer. The tumors were divided into three groups, according to size(&3 cm, 3-5cm and >5 cm). The enhancing patterns of tumor and capsule in the earlyand delayed phase were analysed. The enhancing patterns of the tumor were divided into five types(high, peripheralhigh, mixed, iso and low attenuation) in the early phase and four types(central high, mixed, iso, and low attenuation) in the delayed phase. The enhancing patterns of the capsule were divided into three types such asiso, low and high attenuation. RESULTS: High attenuating lesions in the early phase were as follows : below 3cm 72% ; 3-5cm., 60% ; above 5cm., 49%. Mixed attenuating lesions in the early phase were as follows : below 3cm., 1%; 3-5cm., 22% ; above 5cm., 36%. Thus, most HCCs were high attenuation type in the early phase, but as the tumorbecame larger, less high attenuation and more mixed attenuation was demonstrated(p<0.01). There was no difference of enhancing patterns according to the tumor size in peripheral high, iso and low-attenuating lesions. In the delayed phase most of the hepatomas appeared as totally hypodense lesions. For capsules, the results were as follows : below 3cm., 20% ; 3-5cm.,58% ; above 5cm., 73%. As the tumors became larger, more capsules were demonstrated(p <0.01). The capsules were visualized as iso or low attenuating rim in the early phase and high attenuating rim in the delayed phase. CONCLUSIONS: To determine the enhancing patterns of HCC using spiral CT is considered to be helpful in the diagnosis of HCC.
Capsules
;
Carcinoma, Hepatocellular*
;
Diagnosis
;
Tomography, Spiral Computed*
10.A Case of Encapsulated Fat Necrosis.
Moon Jung CHOI ; Sang Wook LEE ; Jeong Sun HYUN ; Tae Yoon KIM ; Jun Young LEE
Korean Journal of Dermatology 2002;40(4):437-439
Encapsulated fat necrosis is a distinct, benign subcutaneous lesion characterized by histologically non-viable adipose cells surrounded by thin fibrous capsules. We report a case of encapsulated fat necrosis in a 30-year-old woman who had one mobile, subcutaneous nodule on her left shin for 3 years without previous history of trauma. Histopathologically the nodule showed strong PAS positive necrotic adipose tissues encapsulated by fibrous tissue.
Adult
;
Capsules
;
Fat Necrosis*
;
Female
;
Humans