Ağızda Dağılan Tabletler II: In Vitro ve In Vivo Değerlendirilmeleri
Year 2011,
Issue: 1, 59 - 70, 01.01.2011
Senem Sevtap Ölmez
İmran Vural
,
Selma Şahin
Aygün Ertuğrul
Yılmaz Çapan
Abstract
Ağızda dağılan tebletler ADT hasta uyuncu üzerindeki belirgin etkilerinden dolayı oral katı dozaj şekilleri olarak dikkat çekicidirler. ADTler suya gereksinim olmadan tükürükte hızla dağılır ve/veya çözünür ve yutma zorluğu olanlar için üstünlük sağlar. ADTlerin karakterizasyonu için standart bir sistem yok gibi gözükmektedir. ADTlerin değerlendirilmesi friyabilite, sertlik, ıslanma zamanı, su absorpsiyon oranı, in vitro dağılma testi ve çözünme testi ile yapılabilir. Bu derleme, ADTlerin in vitro kalite kontrol testlerini ve klinik çalışmalarını özetlemektedir.
References
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- 29. Klancke, J.: Dissolution Testing of Orally Disintegrating Tablets, Dissolution Technol, 10, 6-8 (2003)
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- 33. Que, L., Wu, W., Cheng, X.Hu, T.: Evaluation of disintegrating time of rapidly disintegrating tablets by a paddle method, Pharm Dev Technol, 11, 295-301 (2006)
- 34. Okuda, Y., Irisawa, Y., Okimoto, K., Osawa, T.Yamashita, S.: A new formulation for orally disintegrating tablets using a suspension spray-coating method, Int J Pharm, 382, 80-87 (2009)
- 35. Shu, T., Suzuki, H., Hironaka, K.Ito, K.: Studies of rapidly disintegrating tablets in the oral cavity using co-ground mixtures of mannitol with crospovidone, Chem Pharm Bull (Tokyo), 50, 193-8 (2002)
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- 37. Fukami, J., Yonemochi, E., Yoshihashi, Y.Terada, K.: Evaluation of rapidly disintegrating tablets containing glycine and carboxymethylcellulose, Int J Pharm, 310, 101-9 (2006)
- 38. Que, L., Wu, W., Cheng, X.Hu, T.: Evaluation of disintegrating time of rapidly disintegrating tablets by a paddle method, Pharmaceutical Development and Technology, 295-301 (2006)
- 39. El-Arini, S.K.Clas, S.D.: Evaluation of disintegration testing of different fast dissolving tablets using the texture analyzer, Pharm Dev Technol, 7, 361-71 (2002)
- 40. Morita, Y., Tsushima, Y., Yasui, M., Termoz, R., Ajioka, J.Takayama, K.: Evaluation of the disintegration time of rapidly disintegrating tablets via a novel method utilizing a CCD camera, Chem Pharm Bull (Tokyo), 50, 1181-6 (2002)
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- 42. Harada, T., Narazaki, R., Nagira, S., Ohwaki, T., aoki, S.Iwamoto, K.: Evaluation of the disintegration properties of commercial famotidine 20 mg orally disintegarting tablets using a simple new test and human sensory test, Chem Pharm Bull, 54, 1072-1075 (2006)
- 43. Ishikawa, T., Koizumi, N., Mukai, B., Utoguchi, N., Fujii, M., Matsumoto, M., Endo, H., Shirotake, S.Watanabe, Y.: Pharmacokinetics of acetaminophen from rapidly disintegrating compressed tablet prepared using microcrystalline cellulose (PH-M-06) and spherical sugar granules, Chem Pharm Bull (Tokyo), 49, 230-2 (2001)
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- 47. Lew, M.F.: Selegiline orally disintegrating tablets for the treatment of Parkinson’s disease, Expert Rev Neurother, 5, 705-12 (2005)
- 48. Iwasaki, K., Yoshikawa, Y., Shibata, N., Takada, K., Sakurai, Y., Takagi, N., Irie, S.Nakamura, K.: Evaluation of fast disintegrating lansoprazole tablet in human subjects, Drug Metab Pharmacokinet, 19, 227-35 (2004)
- 49. Baldi, F.Malfertheiner, P.: Lansoprazole fast disintegrating tablet: a new formulation for an established proton pump inhibitor, Digestion, 67, 1-5 (2003)
- 50. Ahmed, I.S.Aboul-Einien, M.H.: In vitro and in vivo evaluation of a fast-disintegrating lyophilized dry emulsion tablet containing griseofulvin, Eur J Pharm Sci, 32, 58-68 (2007)
- 51. Thyssen, A., Remmerie, B., D’Hoore, P., Kushner, S.Mannaert, E.: Rapidly disintegrating risperidone in subjects with schizophrenia or schizoaffective disorder: a summary of ten phase I clinical trials assessing taste, tablet disintegration time, bioequivalence, and tolerability, Clin Ther, 29, 290-304 (2007)
- 52. Chue, P., Jones, B., Taylor, C.C.Dickson, R.: Dissolution profile, tolerability, and acceptability of the orally disintegrating olanzapine tablet in patients with schizophrenia, Can J Psychiatry, 47, 771-4 (2002)
- 53. Markowitz, J.S., DeVane, C.L., Malcolm, R.J., Gefroh, H.A., Wang, J.S., Zhu, H.J.Donovan, J.L.: Pharmacokinetics of olanzapine after single-dose oral administration of standard tablet versus normal and sublingual administration of an orally disintegrating tablet in normal volunteers, J Clin Pharmacol, 46, 164-71 (2006)
- 54. Shen, Y.C., Lee, M.Y., Lin, C.C.Chen, C.H.: Orally disintegrating olanzapine for the treatment of a manic patient with esophageal stricture plus chronic pharyngitis, Prog Neuropsychopharmacol Biol Psychiatry, 31, 541-2 (2007)
- 55. Barbanti, P., Le Pera, D.Cruccu, G.: Sumatriptan fast-disintegrating/rapid-release tablets in the acute treatment of migraine, Expert Rev Neurother, 7, 927-34 (2007)
Orally disintegrating Tablets II: In Vitro and In Vivo Evaluations
Year 2011,
Issue: 1, 59 - 70, 01.01.2011
Senem Sevtap Ölmez
İmran Vural
,
Selma Şahin
Aygün Ertuğrul
Yılmaz Çapan
Abstract
Orally disintegrating tablets ODTs are attractive oral solid dosage forms as it has significant impact on the patient compliance. ODTs disintegrate and/or dissolve rapidly in the saliva without the need for water and offer an advantage for populations who have difficulty in swallowing. There seems to be lack of a standardized system to characterize ODTs. Evaluation of ODTs can be done by friability, hardness, wetting time, water absorption ratio, in vitro disintegration test and dissolution test. The current article summarizes in vitro quality control tests and clinical studies for ODTs.
References
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- 3. Avrupa Farmakopesi (6th Ed), Strazburg, Fransa, (2007)
- 4. Guidance for Industry Orally Disintegrating Tablets, ABD Besin ve İlaç Yönetmeliği, CDER Data Standards Manual, (2008 Aralık)
- 5. Sastry, S.V., Nyshadham, J.R.Fix, J.A.: Recent technological advances in oral drug delivery - a review, Pharm Sci Technolo Today, 3, 138-145 (2000)
- 6. Bandari, S., Mittapalli, R.K., Gannu, R., Rao, Y.M.: Orodispersible tablets: An overview, Asian Journal of Pharmaceutics, 2-11 (2008)
- 7. Prajapati, B.G.Ratnakar, N.: A review on recent patents on fast dissolving drug delivery system, Int J PharmTech Res, 1, 790-798 (2009)
- 8. Goel, H., Rai, P., Rana, V.Tiwary, A.K.: Orally disintegrating systems: Innovations in formulation and technology, Recent Patents on Drug Delivery & Formulation, 2, 258- 274 (2008)
- 9. Anand, V., Kandarapu, R.Garg, S.: Preparation and evaluation of taste-masked orally disintegrating tablets of prednisolone, Asian Journal of Pharmaceutical Sciences, 2, 227-238 (2007)
- 10. Abdelbary, G., Prinderre, P., Eouani, C., Joachim, J., Reynier, J.P.Piccerelle, P.: The preparation of orally disintegrating tablets using a hydrophilic waxy binder, Int J Pharm, 278, 423-33 (2004)
- 11. Kuno, Y., Kojima, M., Ando, S.Nakagami, H.: Effect of preparation method on properties of orally disintegrating tablets made by phase transition, Int J Pharm, 355, 87-92 (2008)
- 12. Swamy, P.V., Shahidulla, S.M., Shirsand, S.B., Hiremath, S.N.Ali, Y.: Orodispersible tablets of carbamazepine prepared by direct compression method using 32 full factorial design, Dhaka Univ J Pharm Sci, 7, 1-5 (2008)
- 13. Jadon, R.S.vediğ.: Taste masking of Lornoxicam by polymer carrier system and formulation of oral disintegrating tablets, Int J Drug Del, 1, 27-31 (2009)
- 14. Gohel, M., Parikh, R., Brahmbhatt, B.Shah, A.: Improving the tablet characteristics and dissolution profile of ibuprofen by using a novel coprocessed superdisintegrant: A technical note, AAPS PharmSciTech, 8, 13 (2007)
- 15. Dobetti, L.: Fast melting tablets: Developments and technologies, Pharm Technol Drug Deliv, 44-50 (2001)
- 16. Gupta, A., Mishra, A.K., Gupta, V., Bansal, P., Singh, R.Singh, A.K.: Recent Trends of Fast Dissolving Tablet - An Overview of Formulation Technology, International Journal of Pharmaceutical & Biological Archives, 1, 1 - 10 (2010)
- 17. Sznitowska, M., Placzek, M.Klunder, M.: The psysical characteristics of lyophilized tablets containing a model drug in different chemical forms and concentrations, Acta Poloniae Pharmaceutica - Drug Research, 62, 25-29 (2005)
- 18. Corveleyn, S.Remon, J.P.: Formulation and production of rapidly disintegrating tablets by lyophilisation using hydrochloorothiazide as a model drug, Int J Pharm, 152, 215- 225 (1997)
- 19. Bi, Y., Sunada, H., Yonezawa, Y., Danjo, K., Otsuka, A.Iida, K.: Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity, Chem Pharm Bull (Tokyo), 44, 2121-7 (1996)
- 20. Sunada, H., Bi, Y.: Preparation, evaluation and optimization of rapidly disintegrating tablets, Powder Technol, 122, 188-198 (2002)
- 21. Schiermeier, S.Schmidt, P.C.: Fast dispersible ibuprofen tablets, Eur J Pharm Sci, 15, 295-305 (2002)
- 22. Bi, Y.X., Sunada, H., Yonezawa, Y.Danjo, K.: Evaluation of rapidly disintegrating tablets prepared by a direct compression method, Drug Dev Ind Pharm, 25, 571-581 (1999)
- 23. Sugimoto, M., Narisawa, S., Matsubara, K., Yoshino, H., Nakano, M.Handa, T.: Development of manufacturing method for rapidly disintegrating oral tablets using the crystalline transition of amorphous sucrose, Int J Pharm, 320, 71-8 (2006)
- 24. Bi, Y., Yonezawa, Y.Sunada, H.: Rapidly disintegrating tablets prepared by the wet compression method: Mechanism and optimization, J Pharm Sci, 88, 1004-1010 (1999)
- 25. Wagh, M.A., Dilip, K.P., Salunkhe, K.S., Chavan, N.V.Daga, V.R.: Techniques used in orally disintegrating drug delivery system, International Journal of Drug Delivery, 2, 98-107 (2010)
- 26. Bharawaj, S., Jain, V., Sharma, S., Jat, R.C.Jain, S.: Orally disintegrating tablets: A review, Drug Invention Today, 2, 81-88 (2010)
- 27. Rao, N.G.R., Ketan, T.Suresh, D.K.: Formulation and evaluation of mouth dissolving tablets of metoprolol tartrate by sublimation method, International Journal of Pharma and Bio Sciences, 1, 1-14 (2010)
- 28. Siewert, M., Dressman, J., Brown, C.K.Shah, V.P.: FIP/AAPS guidelines to dissolution / in vitro release testing of novel / special dosage forms, AAPS Pharm Sci Tech, 4, Article 7 (2003)
- 29. Klancke, J.: Dissolution Testing of Orally Disintegrating Tablets, Dissolution Technol, 10, 6-8 (2003)
- 30. Rawas-Qalaji, M.M., Simons, F.E.Simons, K.J.: Fast-disintegrating sublingual tablets: effect of epinephrine load on tablet characteristics, AAPS PharmSciTech, 7, E41 (2006)
- 31. Fu, Y., Yang, S., Jeong, S.H., Kimura, S.Park, K.: Orally fast disintegrating tablets: developments, technologies, taste-masking and clinical studies, Crit Rev Ther Drug Carrier Syst, 21, 433-76 (2004)
- 32. Abdelbary, G., Eouani, C., Prinderre, P., Joachim, J., Reynier, J.Piccerelle, P.: Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration, Int J Pharm, 292, 29-41 (2005)
- 33. Que, L., Wu, W., Cheng, X.Hu, T.: Evaluation of disintegrating time of rapidly disintegrating tablets by a paddle method, Pharm Dev Technol, 11, 295-301 (2006)
- 34. Okuda, Y., Irisawa, Y., Okimoto, K., Osawa, T.Yamashita, S.: A new formulation for orally disintegrating tablets using a suspension spray-coating method, Int J Pharm, 382, 80-87 (2009)
- 35. Shu, T., Suzuki, H., Hironaka, K.Ito, K.: Studies of rapidly disintegrating tablets in the oral cavity using co-ground mixtures of mannitol with crospovidone, Chem Pharm Bull (Tokyo), 50, 193-8 (2002)
- 36. Sugimoto, M., Narisawa, S., Matsubara, K., Yoshino, H., Nakano, M.Handa, T.: Effect of formulated ingredients on rapidly disintegrating oral tablets prepared by the crystalline transition method, Chem Pharm Bull (Tokyo), 54, 175-80 (2006)
- 37. Fukami, J., Yonemochi, E., Yoshihashi, Y.Terada, K.: Evaluation of rapidly disintegrating tablets containing glycine and carboxymethylcellulose, Int J Pharm, 310, 101-9 (2006)
- 38. Que, L., Wu, W., Cheng, X.Hu, T.: Evaluation of disintegrating time of rapidly disintegrating tablets by a paddle method, Pharmaceutical Development and Technology, 295-301 (2006)
- 39. El-Arini, S.K.Clas, S.D.: Evaluation of disintegration testing of different fast dissolving tablets using the texture analyzer, Pharm Dev Technol, 7, 361-71 (2002)
- 40. Morita, Y., Tsushima, Y., Yasui, M., Termoz, R., Ajioka, J.Takayama, K.: Evaluation of the disintegration time of rapidly disintegrating tablets via a novel method utilizing a CCD camera, Chem Pharm Bull (Tokyo), 50, 1181-6 (2002)
- 41. Narazaki, R., Harada, T., Takami, N., Kato, Y.Ohwaki, T.: A new method for disintegration studies of rapid disintegrating tablet, Chem Pharm Bull, 52, 704-707 (2004)
- 42. Harada, T., Narazaki, R., Nagira, S., Ohwaki, T., aoki, S.Iwamoto, K.: Evaluation of the disintegration properties of commercial famotidine 20 mg orally disintegarting tablets using a simple new test and human sensory test, Chem Pharm Bull, 54, 1072-1075 (2006)
- 43. Ishikawa, T., Koizumi, N., Mukai, B., Utoguchi, N., Fujii, M., Matsumoto, M., Endo, H., Shirotake, S.Watanabe, Y.: Pharmacokinetics of acetaminophen from rapidly disintegrating compressed tablet prepared using microcrystalline cellulose (PH-M-06) and spherical sugar granules, Chem Pharm Bull (Tokyo), 49, 230-2 (2001)
- 44. Ventura, C.A., Giannone, I., Musumeci, T., Pignatello, R.Puglisi, G.: Technological evaluation and equivalence assessment of lorazepam tablets in rabbits, Pharmazie, 62, 515-8 (2007)
- 45. Golden, G., Honigfeld, G.: Bioequivalence of clozapine orally disintegrating 100-mg tablets compared with clozapine solid oral 100-mg tablets after multiple doses in patients with schizophrenia, Clin Drug Invest, 28, 231-239 (2008)
- 46. Clarke, A., Brewer, F., Johnson, E.S., Mallard, N., Hartig, F., Taylor, S.Corn, T.H.: A new formulation of selegiline: Improved bioavailability and selectivity for MAO-B inhibition, J Neural Transm, 110, 1241-1255 (2003)
- 47. Lew, M.F.: Selegiline orally disintegrating tablets for the treatment of Parkinson’s disease, Expert Rev Neurother, 5, 705-12 (2005)
- 48. Iwasaki, K., Yoshikawa, Y., Shibata, N., Takada, K., Sakurai, Y., Takagi, N., Irie, S.Nakamura, K.: Evaluation of fast disintegrating lansoprazole tablet in human subjects, Drug Metab Pharmacokinet, 19, 227-35 (2004)
- 49. Baldi, F.Malfertheiner, P.: Lansoprazole fast disintegrating tablet: a new formulation for an established proton pump inhibitor, Digestion, 67, 1-5 (2003)
- 50. Ahmed, I.S.Aboul-Einien, M.H.: In vitro and in vivo evaluation of a fast-disintegrating lyophilized dry emulsion tablet containing griseofulvin, Eur J Pharm Sci, 32, 58-68 (2007)
- 51. Thyssen, A., Remmerie, B., D’Hoore, P., Kushner, S.Mannaert, E.: Rapidly disintegrating risperidone in subjects with schizophrenia or schizoaffective disorder: a summary of ten phase I clinical trials assessing taste, tablet disintegration time, bioequivalence, and tolerability, Clin Ther, 29, 290-304 (2007)
- 52. Chue, P., Jones, B., Taylor, C.C.Dickson, R.: Dissolution profile, tolerability, and acceptability of the orally disintegrating olanzapine tablet in patients with schizophrenia, Can J Psychiatry, 47, 771-4 (2002)
- 53. Markowitz, J.S., DeVane, C.L., Malcolm, R.J., Gefroh, H.A., Wang, J.S., Zhu, H.J.Donovan, J.L.: Pharmacokinetics of olanzapine after single-dose oral administration of standard tablet versus normal and sublingual administration of an orally disintegrating tablet in normal volunteers, J Clin Pharmacol, 46, 164-71 (2006)
- 54. Shen, Y.C., Lee, M.Y., Lin, C.C.Chen, C.H.: Orally disintegrating olanzapine for the treatment of a manic patient with esophageal stricture plus chronic pharyngitis, Prog Neuropsychopharmacol Biol Psychiatry, 31, 541-2 (2007)
- 55. Barbanti, P., Le Pera, D.Cruccu, G.: Sumatriptan fast-disintegrating/rapid-release tablets in the acute treatment of migraine, Expert Rev Neurother, 7, 927-34 (2007)