Modified extrusion-spheronization as a technique of microencapsulation for stabilization of choline bitartrate using hydrogenated soya bean oil

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Abstract

Introduction:

Choline bitartrate (CBT) is a vital nutrient for fetal brain development and memory function. It is hygroscopic in nature which is associated with stability related problem during storage such as development of fishy odor and discoloration.

Aim:

Microencapsulation method was adopted to resolve the stability problem and for this hydrogenated soya bean oil (HSO) was used as encapsulating agent.

Materials and Methods:

Industrially feasible modified extrusion-spheronization technique was selected for microencapsulation. HSO was used as encapsulating agent, hydroxypropyl methyl cellulose E5/E15 as binder and microcrystalline cellulose as spheronization aid. Formulated pellets were evaluated for parameters such as flow property, morphological characteristics, hardness-friability index (HFI), drug content, encapsulation efficiency, and in vitro drug release. The optimized formulations were also characterized for particle size (by laser diffractometry), differential scanning calorimetry, powder X-ray diffractometry (PXRD), Fourier transform infrared spectroscopy, and scanning electron microscopy.

Results and Discussions:

The results from the study showed that coating of 90% and 60% CBT was successful with respect to all desired evaluation parameters. Optimized formulation was kept for 6 months stability study as per ICH guidelines, and there was no change in color, moisture content, drug content, and no fishy odor was observed.

Conclusion:

Microencapsulated pellets of CBT using HSO as encapsulating agent were developed using modified extrusion spheronization technique. Optimized formulations, CBT 90% (F5), and CBT 60% (F10), were found to be stable for 4M and 6M, respectively, at accelerated conditions.

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Most cited references 32

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Perinatal choline influences brain structure and function.

D Niculescu, Steven H. Zeisel (2006)

Choline is derived not only from the diet, but also from de novo synthesis. It is important for methyl-group metabolism, the formation of membranes, kidney function, and neurotransmission. When deprived of dietary choline, most adult men and postmenopausal women develop signs of organ dysfunction (fatty liver or muscle damage) and have a decreased capacity to convert homocysteine to methionine. Choline is critical during fetal development, when it influences stem cell proliferation and apoptosis, thereby altering brain structure and function (memory is permanently enhanced in rodents exposed to choline during the latter part of gestation).

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Dual fortification of salt with iodine and microencapsulated iron: a randomized, double-blind, controlled trial in Moroccan schoolchildren.

Michael Zimmermann, Ghada Saad, Christophe Zeder … (2003)

In many developing countries, children are at high risk of both goiter and iron deficiency anemia. In a series of studies in northern Morocco, we developed and tested a dual-fortified salt (DFS) containing iodine and microencapsulated iron. To establish the DFS fortification concentration, we measured salt intake by 3-d weighed food records and estimated iron bioavailability from the local diet by using published algorithms. We then formulated a DFS containing 25 micro g iodine/g salt (as potassium iodide) and 1 mg iron/g salt (as ferrous sulfate hydrate encapsulated with partially hydrogenated vegetable oil). After storage and acceptability trials, we compared the efficacy of the DFS to that of iodized salt in a 9-mo, randomized, double-blind trial in iodine-deficient, 6-15-y-old children (n = 377). Mean salt intake in school-age children was 7-12 g/d, and estimated iron bioavailability from the local diet was 0.4-4.3%. After storage for 20 wk, the DFS and iodized salt were not significantly different in iodine content, and color stability was acceptable when the compounds were added to local meals. During the efficacy trial, urinary iodine concentrations and thyroid volumes improved significantly (P < 0.001 and < 0.05, respectively) from baseline in both groups. At 40 wk, mean hemoglobin concentrations in the DFS group had increased by 14 g/L (P < 0.01), and serum ferritin, transferrin receptor, and zinc protoporphyrin concentrations were significantly better (P < 0.05) in the DFS group than in the iodized salt group. The prevalence of iron deficiency anemia in the DFS group decreased from 35% at baseline to 8% at 40 wk (P < 0.001). A DFS containing iodine and encapsulated iron can be an effective fortification strategy.

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Physicochemical characterization and drug-release properties of celecoxib hot-melt extruded glass solutions.

James Hui, Walton Jones, Kathryn G Andrews … (2010)

The interest in hot-melt extrusion (HME) as a drug delivery technology for the production of glass solutions is growing rapidly. HME glass solutions have a tendency to recrystallize during storage and also typically have a very dense structure, restricting the ingress of dissolution fluid and retarding drug release. In this study, we have used HME to manufacture glass solutions containing celecoxib (CX) and polyvinylpyrrolidone (PVP) and have assessed the use of supercritical carbon dioxide (scCO2) as a pore-forming agent to enhance drug release. Differential scanning calorimetry confirmed the formation of glass solutions following extrusion. All extrudates exhibited a single glass transition temperature (Tg), positioned between the Tg values of CX and PVP. The instability of glass solutions is a significant problem during storage. Stabilization may be improved through the appropriate choice of excipient to facilitate drug–polymer interactions. The Gordon–Taylor equation showed that the Tg values of all extrudates expected on ideal mixing were lower than those observed experimentally. This may be indicative of drug–polymer interactions that decrease free volume and elevate the Tg. Molecular interactions between CX and PVP were further confirmed using Fourier transform infrared and Raman spectroscopy. Storage stability of the extrudates was shown to be dependent on drug loading. Samples containing a higher CX loading were less stable, which we ascribed to decreased Tg and hence increased mobility within the drug–polymer matrix. The solubility of CX was improved through the formulation of extruded glass solutions, but release rate was relatively slow. Exposure of extrudates to scCO2 had no effect on the solid-state properties of CX but did produce a highly porous structure. The drug-release rate from extrudates after scCO2 exposure was significantly higher.

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Author and article information

Journal

Journal ID (nlm-ta): Int J Pharm Investig

Journal ID (iso-abbrev): Int J Pharm Investig

Journal ID (publisher-id): IJPI

Title: International Journal of Pharmaceutical Investigation

Publisher: Medknow Publications & Media Pvt Ltd (India )

ISSN (Print): 2230-973X

ISSN (Electronic): 2230-9713

Publication date (Print): Oct-Dec 2015

Volume: 5

Issue: 4

Pages: 275-283

Affiliations

[1] Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai, Maharashtra, India

Author notes

Address for correspondence: Mr. Avinash Bhaskar Gangurde, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga (E), Mumbai - 400 019, Maharashtra, India. E-mail: gangurde.avinash8@ 123456gmail.com

Article

Publisher ID: IJPI-5-275

DOI: 10.4103/2230-973X.167696

PMC ID: 4675009

SO-VID: 4ccd3083-3ee8-40dc-b946-bbcbf2591d72

License:

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

Modified extrusion-spheronization as a technique of microencapsulation for stabilization of choline bitartrate using hydrogenated soya bean oil

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Abstract

Introduction:

Aim:

Materials and Methods:

Results and Discussions:

Conclusion:

Related collections

Drug Repurposing Research Collection

Most cited references 32

Perinatal choline influences brain structure and function.

Dual fortification of salt with iodine and microencapsulated iron: a randomized, double-blind, controlled trial in Moroccan schoolchildren.

Physicochemical characterization and drug-release properties of celecoxib hot-melt extruded glass solutions.

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