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
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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
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Capsules
4.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
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Pharmaceutical Preparations
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Capsules
5.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
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Pilot Projects
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metronidazole
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
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Dentistry
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Polymers
7.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
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Adjuvants, Pharmaceutic
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Capsules
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drugs
8.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
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Fascia
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Foot
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Joints*
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Ligaments
9.Quantifying evaluation of some pharmaceutical products in the form of tablets and capsules by domestic production according to standards of Vietnamese Pharmacopoeia III
Pharmaceutical Journal 2003;326(6):24-26
Experimental studies were carried out concerning the disintegration of 10 preparation of tablet, capsules with various group of medicinal products, produced and distributed by the Pharmaceutical Enterprise X including tablets of paracetamol, tablet of indomethacine, tablet of isoniazid, tablet of metronidazol, tablet of quinin sulfate, tablet of papaverin hydrochloride, tablet of theophylin and tablet of chloroquin phosphate. Results showed that 9 preparations (90%) satisfied the criterions of disintegration
Pharmaceutical Preparations
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Adjuvants, Pharmaceutic
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Capsules
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drugs
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tablets
10.Analysis methodology of multi element in four herbs of guizhi fuling capsules.
Jin-ling WANG ; Jia-chun LI ; Jun-hua HU ; Wen-zhe HUANG ; Zhen-zhong WANG ; Wei XIAO
China Journal of Chinese Materia Medica 2014;39(21):4123-4126
This paper was focused on establishing a ICP-MS method with microwave digestion for simultaneous determination of lead, copper, arsenic, cadmium, mercury, magnesium, manganese, nickel, thallium in cassia tuckahoe capsule and its five raw herbal materials. Internal standard method was adopted to reduce matrix effect and other interference effects. The method established was shown to be simple with high sensitivity, strong specificity and good reproducibility. Linear relationship is good as R2 ≥ 0.999 3 while the average recovery was among 75.84% - 118.9%. The detection limit was 0.016 - 4.593 μg x L(-1). Data in this paper provided the basis for control of deleterious element in Guizhi Fuling capsules, and further more it was with referencing values for control of deleterious element in other crude drug.
Capsules
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Drugs, Chinese Herbal
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analysis
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Reproducibility of Results