Novel dabigatran etexilate hemisuccinate-loaded polycap: Physicochemical characterisation and in vivo evaluation in beagle dogs

Cho, Jung-Hyun; Kim, Jin Cheul; Kim, Hyung-Seo; Kim, Dong Shik; Kim, Kyeong Soo; Kim, Yong Il; Yong, Chul Soon; Kim, Jong Oh; Youn, Yu Seok; Oh, Kyung Taek; Woo, Jong Soo; Choi, Han‐Gon

doi:10.1016/j.ijpharm.2017.04.028

Cited by 11 publications

(3 citation statements)

References 40 publications

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“…According to the Guidelines on the Investigat of Bioequivalence, the dissolution profiles of the SR layer at pH 6.8 were compared [17, The difference factor (f1) and similarity factor (f2) were determined: f1 = [∑│Rt − Tt│/∑ × 100; f2 = 50 × log{[1 + (1/n)∑ (Rt − Tt)2]−0.5 × 100}, where n represents the numbe comparison time points and Tt and Rt are the dissolved percentages at each time for SR layer and the commercial capsule, respectively [19]. In this study, 0 < f1 < 15 and 50 < 100 were regarded as having similar dissolution patterns between the two formulati [19,20]. The f1 and f2 values between the SR layer and the commercial capsule were 3 and 30.6 at 15%, 25.2 and 38.3 at 19%, 14.8 and 47.1 at 21%, and 11.4 and 56.2 at 2 respectively.…”

Section: Tamsulosin Pelletsmentioning

confidence: 96%

“…where n represents the number of comparison time points and T t and R t are the dissolved percentages at each time for the SR layer and the commercial capsule, respectively [19]. In this study, 0 < f 1 < 15 and 50 < f 2 < 100 were regarded as having similar dissolution patterns between the two formulations [19,20]. The f 1 and f 2 values between the SR layer and the commercial capsule were 36.4 and 30.6 at 15%, 25.2 and 38.3 at 19%, 14.8 and 47.1 at 21%, and 11.4 and 56.2 at 24%, respectively.…”

Section: Tamsulosin Pelletsmentioning

confidence: 99%

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Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol

Cho,

Kim,

Jin

et al. 2023

IJMS

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In this study, we developed a tamsulosin pellet-loaded orally disintegrating tablet (ODT) that is bioequivalent to commercially available products and has improved patient compliance using microcrystalline cellulose (MCC) and mannitol. Utilizing the fluid bed technique, the drug, sustained release (SR) layer, and enteric layer were sequentially prepared by coating MCC pellets with the drug, HPMC, Kollicoat, and a mixture of Eudragit L and Eudragit NE, respectively, resulting in the production of tamsulosin pellets. The tamsulosin pellet, composed of the MCC pellet, drug layer, SR layer, and enteric layer at a weight ratio of 20:0.8:4.95:6.41, was selected because its dissolution was equivalent to that of the commercial capsule. Tamsulosin pellet-loaded ODTs were prepared using tamsulosin pellets and various co-processed excipients. The tamsulosin pellet-loaded ODT composed of tamsulosin pellets, mannitol–MCC mixture, silicon dioxide, and magnesium stearate at a weight ratio of 32.16:161.84:4.0:2.0 gave the best protective effect on the coating process and a dissolution profile similar to that of the commercial capsule. Finally, no significant differences in beagle dogs were observed in pharmacokinetic parameters, suggesting that they were bioequivalent. In conclusion, tamsulosin pellet-loaded ODTs could be a potential alternative to commercial capsules, improving patient compliance.

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Section: Tamsulosin Pelletsmentioning

confidence: 96%

Section: Tamsulosin Pelletsmentioning

confidence: 99%

Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol

Cho,

Kim,

Jin

et al. 2023

IJMS

Self Cite

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“…Derajat kebebasan adalah perbandingan antara jumlah partikel bebas dengan jumlah partikel total (64; 65). Sedangkan rasio reduksi adalah perbandingan ukuran partikel yang masuk ke dalam proses (opening) dibanding dengan ukuran partikel yang keluar dari proses (discharge) (66)(67)(68).…”

Section: Pendahuluanunclassified

A Review Grinding : Teknik dan Prinsip Dasar pada Pengolahan Material

P¹,

A²,

S³

et al. 2018

Preprint

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Grinding merupakan suatu teknik pengecilan ukuran atau pengurangan ukuran dalam batas yang diinginkan. Review ini bertujuan untuk mendapatkan gambaran mengenai prinsip teknik grinding dalam pengolahan material. Metode seperti ini dilakukan untuk material dalam keadaan basah. Hasil pengolahan menggunakan metode grinding berupa material yang berukuran lebih kecil dari material sebelumnya atau dapat berupa mineral berharga yang terpisah dari mineral pengikutnya. Dalam beberapa pengolahan mineral non logam teknik grinding ini diperlukan untuk memenuhi persyaratan pasar.

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Enhanced Chemical Stability of D‐Cycloserine via Tablet Form Containing Magnesium Oxide as an Alkali Stabilizer

Kim

Lee

Kim

et al. 2019

Bulletin Korean Chem Soc

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The purpose of this study was to improve the chemical stability of D-cycloserine via tablet form containing an alkali stabilizer. The influence of alkalizing agents on the stability of D-cycloserine was investigated at 60 C/75% RH for 2 days. The drug stability was evaluated with the D-cycloserine-loaded tablets prepared with various amounts of magnesium oxide using direct compression method. Compared to Dcycloserine powder and a commercial D-cycloserine-loaded product, the long-term drug stability on the chosen tablet was assessed at 40, 60, and 40 C/75% RH during 6 months. Amongst the stabilizers investigated, magnesium oxide most improved the stability of D-cycloserine at the accelerated stress condition. The magnesium oxide/drug ratio of 1 and 2 showed higher remaining drug concentrations than those less than 0.5; however, two formers gave no significant difference in the remaining drug concentrations. Amongst the tablets tested, the formulation composed of D-cycloserine, magnesium oxide, and talc at the weight ratio of 250/250/5 most increased the stability of D-cycloserine. Additionally, due to the alkali and water-proofing property of magnesium oxide, this tablet improved the stability of D-cycloserine compared to the drug powder and commercial product. Hence, this novel tablet with enhanced drug stability would be a candidate for oral pharmaceutical product of D-cycloserine.

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Novel dabigatran etexilate hemisuccinate-loaded polycap: Physicochemical characterisation and in vivo evaluation in beagle dogs

Cited by 11 publications

References 40 publications

Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol

Development of Novel Tamsulosin Pellet-Loaded Oral Disintegrating Tablet Bioequivalent to Commercial Capsule in Beagle Dogs Using Microcrystalline Cellulose and Mannitol

A Review Grinding : Teknik dan Prinsip Dasar pada Pengolahan Material

Enhanced Chemical Stability of D‐Cycloserine via Tablet Form Containing Magnesium Oxide as an Alkali Stabilizer

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