A practical guide to pharmaceutical polymorph screening &amp; selection

Lee, Eun Hee

doi:10.1016/j.ajps.2014.05.002

Cited by 226 publications

(222 citation statements)

References 133 publications

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“…Artinya kristal yang mempunyai karakter disolusi yang bagus ketika baru saja terbentuk, dapat berubah menjadi kristal bentuk lain yang mempunyai karakter disolusi yang jelek kembali setelah disimpan. 15 Uji stabilitas penyimpanan merupakan bagian penting program uji bahan obat karena ketidakstabilan produk ditentukan oleh tiga syarat utama yaitu kualitas, efikasi, dan keamanan. Selama penyimpanan sediaan dapat terjadi perubahan-perubahan karakteristik fisikokimia.…”

Section: 2unclassified

Disolusi Kapsul Dispersi Padat Piroksikam-PEG 6000 Selama Penyimpanan

Binarjo

Khotimah²

2017

IJPST

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AbstrakKelarutan piroksikam yang rendah mempengaruhi laju disolusi sebagai penentu bioavaibilitas. Pembuatan dispersi padat dengan piroksikam-polietilenglikol dapan meningkatkan laju disolusinya. Tujuan penelitian ini adalah untuk mengetahui pengaruh pembentukan dispersi padat piroksikampolietilenglikol 6000 (PEG 6000) terhadap laju disolusi kapsul piroksikam selama 1 bulan penyimpanan. Rekristal piroksikam (R) dan dispersi padat piroksikam-PEG 6000 (DP) dibuat dengan metode pelarut menggunakan campuan aseton-etanol (1:1), keduanya bersama dengan piroksikam tanpa modifikasi (P) dikapsul dan disimpan selama 1 bulan. Uji disolusi dilakukan setiap minggu. Efisiensi disolusi 60 menit (DE60), prosentase disolusi 45 menit (C45), dan waktu untuk 80% terdisolusi (t80) digunakan sebagai parameter disolusi. Kurva hubungan DE60, C45, dan t80 terhadap waktu penyimpanan dilihat slopenya sebagai parameter stabilitas. Hasil percobaan menunjukkan bahwa Kapsul P dan DP menunjukkan nilai DE60, C45, dan t80 yang stabil selama penyimpanan (slope=0, p>0.05), demikian juga nilai t80 kapsul R. Sedangkan DE60 dan C45 kapsul R selama penyimpanan terus menurun dengan slope -0,636 %/hari dan -0,171 mg/hari. Dapat disimpulkan bahwa DP yang dibuat dengan metode pelarut campuran aseton dan etanol (1:1) menunjukkan profil disolusi yang stabil selama penyimpanan 1 bulan.. Kata kunci : disolusi, piroksikam, dispersi padat, polietilenglikol 6000, stabilitas Dissolution Of Solid Dispersion Piroxicam-PEG 6000 Capsules During Storage AbstractThe low solubility of piroxicam affect its rate of dissolution as bioavailability limiting factor. Solid dispersion using polyethilenglycol can improve its dissolution rate. This research was aimed to determine the effect of piroxicam-polyethylenglycol 6000 (PEG 6000) solid dispersion formation on the dissolution rate of piroxicam capsules during storage for 1 month. The piroxicam recrystal (R) and solid dispersion of piroxicam-PEG 6000 (DP) were prepared by solvent method using acetone-ethanol (1:1), these two bulk and unmodified piroxicam (P) as control than be capsulated and stored for 4. Their dissolution were tested every week. Sixty minutes dissolution efficiency (DE60), percent drug dissolved in 45 minutes (C45), and time to dissolve 80% of drug (t80) were used as dissolution parameters. The slope of the plot of these dissolution parameters as a function of time storage was used as a stability indicator. The result show that P and DP capsules have a constant DE60, C45, and t80 during storage (slope=0, p>0.05), also the data of t80 of R capsule. DE60 and C45 of R capsule is going lower during the storage with the slope of -0,636 %/day and -0,171 mg/day. It can be concluded that DP prepared by solvent method using acetoneethanol (1:1) shows the stable dissolution profiles during storage for 1 month.

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Section: 2unclassified

Disolusi Kapsul Dispersi Padat Piroksikam-PEG 6000 Selama Penyimpanan

Binarjo

Khotimah²

2017

IJPST

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“…Considering the widespread use of MBZ in deworming programs, scientists and health professionals worry about the quality parameters of the active pharmaceutical ingredients (API) in order to identify the emergence of any drug resistance [7][8][9]. Among the quality parameters of a drug that may affect its clinical efficiency and performance is polymorphism.…”

Section: Introductionmentioning

confidence: 99%

Quantitative analysis of mebendazole polymorphs in pharmaceutical raw materials using near-infrared spectroscopy

Silva

Gonçalves

Vasconcelos

et al. 2015

Journal of Pharmaceutical and Biomedical Analysis

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“…13 Other methods to obtain polymorphs are being researched, such as computational structure prediction, vapor exposure, crystallization on treated surfaces and capillary crystallization. [14][15][16][17] Recently, nanoscale confinement methods such as crystallization in controlled pore glass and nanodrops have shown great utility in obtaining metastable polymorphs of numerous pharmaceutical compounds. [18][19][20][21][22] These results suggest that there is a fundamental connection between confined environments and metastable crystallization.…”

Section: Solid Phases and Polymorphismmentioning

confidence: 99%

Controlling Polymorphism in Pharmaceutical Compounds Using Solution Shearing

Guthrie

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A practical guide to pharmaceutical polymorph screening & selection

Cited by 226 publications

References 133 publications

Disolusi Kapsul Dispersi Padat Piroksikam-PEG 6000 Selama Penyimpanan

Disolusi Kapsul Dispersi Padat Piroksikam-PEG 6000 Selama Penyimpanan

Quantitative analysis of mebendazole polymorphs in pharmaceutical raw materials using near-infrared spectroscopy

Controlling Polymorphism in Pharmaceutical Compounds Using Solution Shearing

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