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Design and development of solid nanoparticulate dosage forms of telmisartan for bioavailability enhancement by integration of experimental design and principal component analysis.

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Title: Design and development of solid nanoparticulate dosage forms of telmisartan for bioavailability enhancement by integration of experimental design and principal component analysis.
Authors: Patel, Jaydeep1 jmpatel7@gmail.com, Dhingani, Anjali1, Garala, Kevin1, Raval, Mihir2, Sheth, Navin2
Source: Powder Technology. May2014, Vol. 258, p331-343. 13p.
Subjects: Dosage forms of drugs, Bioavailability, Principal components analysis, Nanostructured materials, Oral medicine, Drug development, Drug design
Abstract: Abstract: Aim of the present investigation was to develop nanoparticulate solid oral dosage forms of a poorly water soluble antihypertensive agent, telmisartan (TLM) by converting the optimized batch of drug loaded nanosuspensions into a tablet dosage form using lyophilization technique. The TLM loaded nanosuspensions were optimized by implementation of 32 full factorial design along with principal component analysis (PCA) with concentration of stabilizer and amount of milling agents as factors. The optimized batch of TLM loaded nanosuspension exhibited a mean particle size of 334.67±10.43nm. The results of various instrumental techniques illustrated retention of drug crystallinity after milling and lyophilization. The results of in vitro drug release study of tablets containing drug nanocrystals revealed remarkable improvement in the dissolution rate as compared to the marketed tablet (Sartel® 20). The results of in vivo pharmacokinetic study on Wister rats revealed 1.5-fold enhancement in oral bioavailability for tablets containing TLM nanocrystals against the marketed tablets. The present study proposed nanosuspension as a suitable approach for developing nanosized solid oral dosage forms of poorly water soluble drugs like telmisartan using design of experiment and principal component analysis as two important paradigms of quality by design technique. [Copyright &y& Elsevier]
Copyright of Powder Technology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Engineering Source
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DbLabel: Engineering Source
An: 95630376
AccessLevel: 6
PubType: Academic Journal
PubTypeId: academicJournal
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  Data: Design and development of solid nanoparticulate dosage forms of telmisartan for bioavailability enhancement by integration of experimental design and principal component analysis.
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  Data: <searchLink fieldCode="JN" term="%22Powder+Technology%22">Powder Technology</searchLink>. May2014, Vol. 258, p331-343. 13p.
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  Data: <searchLink fieldCode="DE" term="%22Dosage+forms+of+drugs%22">Dosage forms of drugs</searchLink><br /><searchLink fieldCode="DE" term="%22Bioavailability%22">Bioavailability</searchLink><br /><searchLink fieldCode="DE" term="%22Principal+components+analysis%22">Principal components analysis</searchLink><br /><searchLink fieldCode="DE" term="%22Nanostructured+materials%22">Nanostructured materials</searchLink><br /><searchLink fieldCode="DE" term="%22Oral+medicine%22">Oral medicine</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+development%22">Drug development</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+design%22">Drug design</searchLink>
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  Data: Abstract: Aim of the present investigation was to develop nanoparticulate solid oral dosage forms of a poorly water soluble antihypertensive agent, telmisartan (TLM) by converting the optimized batch of drug loaded nanosuspensions into a tablet dosage form using lyophilization technique. The TLM loaded nanosuspensions were optimized by implementation of 32 full factorial design along with principal component analysis (PCA) with concentration of stabilizer and amount of milling agents as factors. The optimized batch of TLM loaded nanosuspension exhibited a mean particle size of 334.67±10.43nm. The results of various instrumental techniques illustrated retention of drug crystallinity after milling and lyophilization. The results of in vitro drug release study of tablets containing drug nanocrystals revealed remarkable improvement in the dissolution rate as compared to the marketed tablet (Sartel® 20). The results of in vivo pharmacokinetic study on Wister rats revealed 1.5-fold enhancement in oral bioavailability for tablets containing TLM nanocrystals against the marketed tablets. The present study proposed nanosuspension as a suitable approach for developing nanosized solid oral dosage forms of poorly water soluble drugs like telmisartan using design of experiment and principal component analysis as two important paradigms of quality by design technique. [Copyright &y& Elsevier]
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  Data: <i>Copyright of Powder Technology is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1016/j.powtec.2014.03.001
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        Text: English
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      – SubjectFull: Bioavailability
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      – SubjectFull: Principal components analysis
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              Text: May2014
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