Towa Pharmaceutical Co.

Japan

Towa Pharmaceutical Co.

Japan
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Patent
University of Tokyo and Towa Pharmaceutical Co. | Date: 2017-01-18

The present invention pertains to spherical water-dispersible amorphous particles having a particle diameter of 10-990 nm and a PDI of 0.01-0.5, wherein the amorphous particles contain an organic compound having a molecular weight of 50-1500, and a method for preparing the same.


Okuda Y.,Towa Pharmaceutical Co. | Irisawa Y.,Towa Pharmaceutical Co. | Okimoto K.,Towa Pharmaceutical Co. | Osawa T.,Towa Pharmaceutical Co. | Yamashita S.,Setsunan University
International Journal of Pharmaceutics | Year: 2012

The aim of this study is to design a new orally disintegrating tablet (ODT) containing micronized ethylcellulose (MEC). The new ODT was prepared by physical mixing of rapidly disintegrating granules (RDGs) with MEC. To obtain RDGs, mannitol was spray-coated with a suspension of corn starch and crospovidone (9:1, w/w ratio) using a fluidized-bed granulator (suspension spray-coating method). The new ODTs were evaluated for their hardness, friability, thickness, internal structure (X-ray-CT scanning), in vivo disintegration time, and water absorption rate. Since MEC increases tablet hardness by increasing the contact frequency between the granules, the new ODTs could obtain high hardness (>50 N) and low friability (<0.5%) with relatively low compression force. In addition, fine capillary channels formed in ODTs facilitated the wicking action and enabled rapid disintegration in vivo (<30 s). On the other hand, since MEC has low hygroscopicity, the tablet hardness of ODTs containing MEC remained high for 1 month in high-humidity conditions. In conclusion, the new ODTs containing MEC developed in this study possessed superior properties for clinical use and are expected to be applied for a wide range of functionally released drugs for bitter taste masking, sustained release, and controlled release (pH-dependent film coating, matrix, and microcapsule). © 2011 Elsevier B.V. All rights reserved.


Fukui-Soubou M.,Towa Pharmaceutical Co. | Terashima H.,Towa Pharmaceutical Co. | Kawashima K.,Towa Pharmaceutical Co. | Utsunomiya O.,Towa Pharmaceutical Co. | Terada T.,Towa Pharmaceutical Co.
Drugs in R and D | Year: 2011

Objective: The aim of this study was to confirm the efficacy, safety, and expected palatability of amlodipine orally disintegrating tablets (ODT) [RACTAB ® formulation (Towa, Osaka, Japan)]. We report the re-analyzed results of 1687 cases in clinical settings obtained through postmarketing surveillance in Japan. Method: Study subjects were patients receiving treatment for the first time with amlodipine ODT for hypertension under routine care. A multicenter central registration system was used for this prospective survey. The survey was conducted from October 2008 to October 2010. The observational period was 12 weeks, during which time surveys on outpatient blood pressure, adverse events, palatability, etc. were conducted. Results: Blood pressure stabilized following treatment, and both systolic and diastolic blood pressures were favorably controlled. Adverse events observed were not significantly different from those observed during drug use trials of amlodipine formulations reported in 2003. Moreover, palatability of amlodipine ODT showed a 99.6% (227 of 228 cases) favorable patient acceptance, which is consistent with the initial design concept of RACTAB ® formulation. Conclusions: The results of this postmarketing surveillance study indicated that the efficacy, safety, and palatability of amlodipine ODT met our expectations (dissolves quickly in the mouth, tastes good, and is not rough on the tongue). Accordingly, amlodipine ODT are believed to be an easy-to-use formulation for prescribing doctors, dispensing pharmacists, and patients receiving treatment. © 2011 Vergani & Rusconi, publisher and licensee Adis Data Information BV.


Saibi Y.,Showa University | Sato H.,Showa University | Tachiki H.,Towa Pharmaceutical Co.
AAPS PharmSciTech | Year: 2012

The present study was aimed to predict the absorption profile of a risperidone immediate release tablet (IR) and to develop the level A in vitro-in vivo correlation (IVIVC) of the drug using the gastrointestinal simulation based on the advanced compartmental absorption and transit model implemented in GastroPlus™. Plasma concentration data, physicochemical, and pharmacokinetic properties of the drug were used in building its absorption profile in the gastrointestinal tract. Since the fraction absorbed of risperidone in simulation was more than 90% with low water solubility, the drug met the criteria of class II of the Biopharmaceutics Classification System. The IVIVC was developed based on the model built using the plasma data and the in vitro dissolution data in several dissolution media based on the Japanese Guideline for Bioequivalence Studies of Generic Products. The gastrointestinal absorption profile of risperidone was successfully predicted. A level A IVIVC was also successfully developed in all dissolution media with percent prediction error for Cmax and the area under the curve less than 10% for both reference and test drug. © 2012 American Association of Pharmaceutical Scientists.


Okuda Y.,Towa Pharmaceutical Co. | Okamoto Y.,Towa Pharmaceutical Co. | Irisawa Y.,Towa Pharmaceutical Co. | Okimoto K.,Towa Pharmaceutical Co. | And 2 more authors.
Chemical and Pharmaceutical Bulletin | Year: 2014

The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODT RAC). ODTRAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODTRAC containing ECP-T exhibited high hardness (>50 N) and low friability (<0.5%) with a relatively low compression force. After tableting, the structure of ECP-T in ODTRAC remained intact and no damage was observed on the surface. ECP-T recovered from ODTRAC showed the same dissolution profile of TAM in Japanese Pharmacopoeia (JP) 1st and JP 2nd media as that of intact ECP-T, which indicated that the tableting process did not affect the acid-resistibility of the particle. In addition, ODTRAC rapidly disintegrated in vivo (< 30 s), even at a high compression force (at 9 kN). These findings clearly suggest that RACTAB® technology is a useful approach to prepare ODTs containing enteric-coated particles. © 2014 The Pharmaceutical Society of Japan.


Sugiura T.,University of Shizuoka | Sugiura T.,Towa Pharmaceutical Co. | Uchida S.,University of Shizuoka | Namiki N.,University of Shizuoka
Chemical and Pharmaceutical Bulletin | Year: 2012

Orally disintegrating tablets (ODTs) are useful for improving benefits for patients of various ages. Masking the unpleasant taste of a drug is an important factor in the compliance of patients who take ODTs. We evaluated the taste acceptability effects of various taste-masking methods on bitter famotidine ODTs as a clinical pharmacological study. The following methods were tested to compare taste-masking effects: physical masking by spray-coating famotidine with ethyl cellulose versus organoleptic masking with added sweetener and flavor. The ODT samples were prepared as single or combinations of each taste-masking method using a novel suspension spray-coating method including a placebo. A total of 31 healthy volunteers were enrolled in this randomized, double-blind study and asked to score their bitterness, sweetness and total palate impressions by 100 mm visual analogue scale (VAS). VAS scores were significantly improved by the physical and organoleptic methods as compared to without taste-masked ODTs. Furthermore, the combination of both taste-masking methods was most effective for improving palatability and VAS scores were similar to those of placebo ODTs. The results of this study suggest that different taste-masking mechanisms function cooperatively. © 2012 The Pharmaceutical Society of Japan.


Patent
University of Tokyo and Towa Pharmaceutical Co. | Date: 2015-03-09

The present invention pertains to spherical water-dispersible amorphous particles having a particle diameter of 10-990 nm and a PDI of 0.01-0.5, wherein the amorphous particles contain an organic compound having a molecular weight of 50-1500, and a method for preparing the same.


Trademark
Towa Pharmaceutical Co. | Date: 2011-07-01

Pharmaceuticals. Full line of prescription and over-the-counter pharmaceutical preparations for humans. Pharmaceutical goods testing or research.


Trademark
Towa Pharmaceutical Co. | Date: 2010-03-12

Pharmaceuticals. Full line of prescription and over the counter pharmaceutical preparations for humans. Testing or research of pharmaceutical goods or the provision of information related to these services and testing or research of medicine, pharmaceuticals, medical care or healthcare or the provision of information related to these services.


Trademark
Towa Pharmaceutical Co. | Date: 2010-12-03

Pharmaceuticals. Full line of prescription and over-the-counter pharmaceutical preparations for humans. Pharmaceutical product testing and research.

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