Literature DB >> 16902814

Use of a dynamic in vitro lipolysis model to rationalize oral formulation development for poor water soluble drugs: correlation with in vivo data and the relationship to intra-enterocyte processes in rats.

Arik Dahan1, Amnon Hoffman.   

Abstract

PURPOSE: To examine the correlation between the in vitro solubilization process of lipophilic compounds from different lipid solutions and the corresponding in vivo oral bioavailability data. In particular, to assess the influence of intra-enterocyte processes (metabolism and lymphatic absorption) on this correlation.
MATERIALS AND METHODS: The dissolution of progesterone and vitamin D3 in long (LCT), medium (MCT) and short (SCT) chain triglyceride solutions were tested in a dynamic in vitro lipolysis model. The absolute oral bioavailability of the drugs from the tested formulations was investigated in rats. Vitamin D3 bioavailability was also examined following lymphatic transport blockage induced by cycloheximide (3 mg/kg).
RESULTS: The dynamic in vitro lipolysis experiments indicated a rank order of MCT > LCT > SCT for both progesterone and vitamin D3. The bioavailability of progesterone correlated with the in vitro data, despite its significant pre-systemic metabolism. For vitamin D3, an in vivo performance rank order of LCT > MCT > SCT was obtained. However, when the lymphatic transport was blocked the bioavailability of vitamin D3 correlated with in vitro data.
CONCLUSIONS: The in vitro lipolysis model is useful for optimization of oral lipid formulations even in the case of pre-systemic metabolism in the gut. However, when lymphatic transport is a significant route of absorption, the in vitro lipolysis data may not be predictive for actual in vivo absorption.

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Year:  2006        PMID: 16902814     DOI: 10.1007/s11095-006-9054-x

Source DB:  PubMed          Journal:  Pharm Res        ISSN: 0724-8741            Impact factor:   4.200


  25 in total

1.  Kinetics of drug action in disease states. XXIX. Effect of experimental nephrotic syndrome on the pharmacodynamics of heptabarbital: implications of severe hypoalbuminemia.

Authors:  A Hoffman; G Levy
Journal:  J Pharmacol Exp Ther       Date:  1989-04       Impact factor: 4.030

2.  Uptake of lipophilic drugs by plasma derived isolated chylomicrons: linear correlation with intestinal lymphatic bioavailability.

Authors:  Pavel Gershkovich; Amnon Hoffman
Journal:  Eur J Pharm Sci       Date:  2005-09-02       Impact factor: 4.384

3.  A conscious dog model for assessing the absorption, enterocyte-based metabolism, and intestinal lymphatic transport of halofantrine.

Authors:  S M Khoo; G A Edwards; C J Porter; W N Charman
Journal:  J Pharm Sci       Date:  2001-10       Impact factor: 3.534

4.  Evaluation of a chylomicron flow blocking approach to investigate the intestinal lymphatic transport of lipophilic drugs.

Authors:  Arik Dahan; Amnon Hoffman
Journal:  Eur J Pharm Sci       Date:  2005-03       Impact factor: 4.384

5.  Enzymatic characterization of lipid-based drug delivery systems.

Authors:  Helena Ljusberg-Wahren; Flemming Seier Nielsen; Mattias Brogård; Emma Troedsson; Anette Müllertz
Journal:  Int J Pharm       Date:  2005-07-25       Impact factor: 5.875

6.  Separation and characterization of the colloidal phases produced on digestion of common formulation lipids and assessment of their impact on the apparent solubility of selected poorly water-soluble drugs.

Authors:  Greg A Kossena; Ben J Boyd; Christopher J H Porter; William N Charman
Journal:  J Pharm Sci       Date:  2003-03       Impact factor: 3.534

7.  Solubilisation of poorly water-soluble drugs during in vitro lipolysis of medium- and long-chain triacylglycerols.

Authors:  Janne Ørskov Christensen; Kirsten Schultz; Birgitte Mollgaard; Henning Gjelstrup Kristensen; Anette Mullertz
Journal:  Eur J Pharm Sci       Date:  2004-11       Impact factor: 4.384

8.  A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability.

Authors:  G L Amidon; H Lennernäs; V P Shah; J R Crison
Journal:  Pharm Res       Date:  1995-03       Impact factor: 4.200

9.  Use of in vitro lipid digestion data to explain the in vivo performance of triglyceride-based oral lipid formulations of poorly water-soluble drugs: studies with halofantrine.

Authors:  Christopher J H Porter; Ann Marie Kaukonen; Agnes Taillardat-Bertschinger; Ben J Boyd; Jacquelyn M O'Connor; Glenn A Edwards; William N Charman
Journal:  J Pharm Sci       Date:  2004-05       Impact factor: 3.534

10.  [Intestinal lymphatic absorption of labelled oleic acid in the normal rat and rat treated with actidione-cycloheximide or acetoxycycloheximide].

Authors:  A Bernard; H Carlier
Journal:  C R Seances Acad Sci III       Date:  1981-01-05
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  27 in total

Review 1.  The solubility-permeability interplay and its implications in formulation design and development for poorly soluble drugs.

Authors:  Arik Dahan; Jonathan M Miller
Journal:  AAPS J       Date:  2012-03-06       Impact factor: 4.009

2.  Increasing the proportional content of surfactant (Cremophor EL) relative to lipid in self-emulsifying lipid-based formulations of danazol reduces oral bioavailability in beagle dogs.

Authors:  Jean F Cuiné; William N Charman; Colin W Pouton; Glenn A Edwards; Christopher J H Porter
Journal:  Pharm Res       Date:  2007-02-15       Impact factor: 4.200

Review 3.  Transforming lipid-based oral drug delivery systems into solid dosage forms: an overview of solid carriers, physicochemical properties, and biopharmaceutical performance.

Authors:  Angel Tan; Shasha Rao; Clive A Prestidge
Journal:  Pharm Res       Date:  2013-06-18       Impact factor: 4.200

4.  Recent advances in lipid-based formulation technology.

Authors:  Christopher J H Porter; Hywel D Williams; Natalie L Trevaskis
Journal:  Pharm Res       Date:  2013-10-26       Impact factor: 4.200

5.  Insights into drug precipitation kinetics during in vitro digestion of a lipid-based drug delivery system using in-line raman spectroscopy and mathematical modeling.

Authors:  Cordula Stillhart; Georgios Imanidis; Martin Kuentz
Journal:  Pharm Res       Date:  2013-02-28       Impact factor: 4.200

6.  The Effect of Digestion and Drug Load on Halofantrine Absorption from Self-nanoemulsifying Drug Delivery System (SNEDDS).

Authors:  Maria Høtoft Michaelsen; Kishor M Wasan; Olena Sivak; Anette Müllertz; Thomas Rades
Journal:  AAPS J       Date:  2016-01       Impact factor: 4.009

7.  Effect of lipolysis on drug release from self-microemulsifying drug delivery systems (SMEDDS) with different core/shell drug location.

Authors:  Jianbin Zhang; Yan Lv; Shan Zhao; Bing Wang; Mingqian Tan; Hongguo Xie; Guojun Lv; Xiaojun Ma
Journal:  AAPS PharmSciTech       Date:  2014-02-20       Impact factor: 3.246

8.  Dietary fats and pharmaceutical lipid excipients increase systemic exposure to orally administered cannabis and cannabis-based medicines.

Authors:  Atheer Zgair; Jonathan Cm Wong; Jong Bong Lee; Jatin Mistry; Olena Sivak; Kishor M Wasan; Ivo M Hennig; David A Barrett; Cris S Constantinescu; Peter M Fischer; Pavel Gershkovich
Journal:  Am J Transl Res       Date:  2016-08-15       Impact factor: 4.060

9.  Improved oral bioavailability of BCS class 2 compounds by self nano-emulsifying drug delivery systems (SNEDDS): the underlying mechanisms for amiodarone and talinolol.

Authors:  Anna Elgart; Irina Cherniakov; Yanir Aldouby; Abraham J Domb; Amnon Hoffman
Journal:  Pharm Res       Date:  2013-05-18       Impact factor: 4.200

10.  Lipid-based formulations for danazol containing a digestible surfactant, Labrafil M2125CS: in vivo bioavailability and dynamic in vitro lipolysis.

Authors:  Anne Larsen; René Holm; Mette Lund Pedersen; Anette Müllertz
Journal:  Pharm Res       Date:  2008-07-01       Impact factor: 4.200

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