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Journal articles on the topic 'Gelucire®'

Author: Grafiati

Published: 4 June 2021

Last updated: 14 February 2022

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1

Bertoni, Serena, Beatrice Albertini, and Nadia Passerini. "Different BCS Class II Drug-Gelucire Solid Dispersions Prepared by Spray Congealing: Evaluation of Solid State Properties and In Vitro Performances." Pharmaceutics 12, no. 6 (2020): 548. http://dx.doi.org/10.3390/pharmaceutics12060548.

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Delivery of poorly water soluble active pharmaceutical ingredients (APIs) by semi-crystalline solid dispersions prepared by spray congealing in form of microparticles (MPs) is an emerging method to increase their oral bioavailability. In this study, solid dispersions based on hydrophilic Gelucires® (Gelucire® 50/13 and Gelucire® 48/16 in different ratio) of three BCS class II model compounds (carbamazepine, CBZ, tolbutamide, TBM, and cinnarizine, CIN) having different physicochemical properties (logP, pKa, Tm) were produced by spray congealing process. The obtained MPs were investigated in terms of morphology, particles size, drug content, solid state properties, drug-carrier interactions, solubility, and dissolution performances. The solid-state characterization showed that the properties of the incorporated drug had a profound influence on the structure of the obtained solid dispersion: CBZ recrystallized in a different polymorphic form, TBM crystallinity was significantly reduced as a result of specific interactions with the carrier, while smaller crystals were observed in case of CIN. The in vitro tests suggested that the drug solubility was mainly influenced by carrier composition, while the drug dissolution behavior was affected by the API solid state in the MPs after the spray congealing process. Among the tested APIs, TBM-Gelucire dispersions showed the highest enhancement in drug dissolution as a result of the reduced drug crystallinity.

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2

Notario-Pérez, Fernando, Raúl Cazorla-Luna, Araceli Martín-Illana, Roberto Ruiz-Caro, Juan Peña, and María-Dolores Veiga. "Tenofovir Hot-Melt Granulation using Gelucire® to Develop Sustained-Release Vaginal Systems for Weekly Protection against Sexual Transmission of HIV." Pharmaceutics 11, no. 3 (2019): 137. http://dx.doi.org/10.3390/pharmaceutics11030137.

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Hot-melt granulation is a technique used to obtain granules by dispersing a drug in polymers at a high temperature. Tenofovir, an antiretroviral drug with proven activity as a vaginal microbicide, was dispersed in melted Gelucire® (or a mixture of different Gelucire®) to obtain drug-loaded granules. Studies performed on the granules proved that the drug is not altered in the hot-melt granulation process. The granules obtained were included in a matrix formed by the hydrophilic polymers hydroxypropylmethylcellulose and chitosan to obtain vaginal tablets that combine different mechanisms of controlled release: The Gelucire® needs to soften to allow the release of the Tenofovir, and the hydrophilic polymers must form a gel so the drug can diffuse through it. The studies performed with the tablets were swelling behavior, Tenofovir release, and ex vivo mucoadhesion. The tablets containing granules obtained with Tenofovir and Gelucire® 43/01 in a ratio of 1:2 in a matrix formed by hydroxypropylmethylcellulose and chitosan in a ratio of 1.9:1 were selected as the optimal formulation, since they release Tenofovir in a sustained manner over 216h and remain attached to the vaginal mucosa throughout. A weekly administration of these tablets would therefore offer women protection against the sexual transmission of HIV.

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3

Montoussé, C., M. Pruvost, F. Rodriguez, and C. Brossard. "Extrusion–Spheronization Manufacture of Gelucire® Matrix Beads." Drug Development and Industrial Pharmacy 25, no. 1 (1999): 75–80. http://dx.doi.org/10.1081/ddc-100102144.

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4

Patnaik, Sandeep, K. Madhusudhana Rao, and Vijay Sai. "Cytotoxicity Studies on Naproxen and Piroxicam Nanoformulations." Asian Journal of Pharmaceutical Research and Development 8, no. 3 (2020): 87–94. http://dx.doi.org/10.22270/ajprd.v8i3.754.

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Caco-2 cells were used as in vitro models to assess the cell viability characteristics of the carriers Soluplus®, Gelucire 50/13 and PVP K25 and the nanoformulations of Naproxen and Piroxicam. The assessment of cell viability was done using the tetrazolium salt based MTT assay. Gelucire 50/13 and its NFs were observed to have slightly higher cytotoxicity than PVP and Soluplus® and their respective NFs. All the NFs were observed to follow the cytotoxicity trend of the polymers. Our results show that no significant decrease in cell viability was seen until 0.01% concentration of Gelucire 50/13 for 12-h exposure. The NFs as well as the polymers alone had no significant effect on the viability of Caco-2 cells below 0.01% concentrations. The intestine has a protective mucous layer, whereas the cell culture monolayers do not. The intestinal tissues also have more capacity to recover from trauma than the cultured cells. Hence the present NFs can be expected to show lesser cytotoxicity when subjected to in vivo studies.

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5

Kumar, Sacheen, and Jaspreet K. Randhawa. "Paliperidone-loaded spherical solid lipid nanoparticles." RSC Adv. 4, no. 57 (2014): 30186–92. http://dx.doi.org/10.1039/c4ra03107e.

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Gelucire® 50/13, a macrogol glyceride, was used as a surfactant for the preparation and stabilization of paliperidone-loaded Capmul® GMS-50K matrix-based solid lipid nanoparticles (SLNs). The homogeneously distributed paliperidone did not affect the crystal structure of the lipid matrix in the SLNs.

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6

Svensson, A., C. Neves, and B. Cabane. "Hydration of an amphiphilic excipient, Gelucire® 44/14." International Journal of Pharmaceutics 281, no. 1-2 (2004): 107–18. http://dx.doi.org/10.1016/j.ijpharm.2004.06.005.

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7

Momoh, Mumini A., Calister E. Ugwu, Tenderwealth Clement Jackson, and Ngumezi C. Udodiri. "Sustained release formulation of metformin-solid dispersion based on gelucire 50/13- PEG4000: an in vitro study." International Journal of Drug Delivery 9, no. 3 (2017): 52. http://dx.doi.org/10.5138/09750215.2162.

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<p>Metformin is a hydrophilic hypoglycemic agent with permeability and short half-life problems which leads to its low bioavailability. Solid dispersion is one of the unique approaches, to improve bioavailability profiles of drugs. The aim of this study was to prepare and evaluate solid dispersions (SDs) of metformin with polyethylene glycol 4000 (PEG 4000) and Gelucire®50/13 in order to increase its permeability and bioavailability. Solid dispersions of Metformin containing various ratios of PEG 4000: Gelucire®50/13 (1:1, 1:2, 2:1, 1:4, 4:1 as Batch A, Batch B, Batch C, Batch D and Batch E) were prepared using solvent evaporation and fusion techniques. The physical mixtures which served as controls were also prepared. The SDs were evaluated using encapsulation efficiency, percentage yield. The formulations were also characterized with FTIR and DSC. The in vitro drug release studies were also evaluated. The results obtained showed that solid dispersion formulations at pH, 1.2 and 7.4 demonstrated higher release rates than the pure drug. The SDs showed high drug release rates and encapsulation efficiency (% EE) although Batch C containing PEG 4000 and Gelucire 50/13 in the ratio of 2:1 appeared as the batch with most % EE, drug release with broad melting peak. The release rate of metformin increased with increasing amount of PEG 4000. Batch C, SDs containing PEG 4000 and Gelucire 50/13 in the ratio of 2:1 were found to be the most optimized batch with enhanced encapsulation efficiency, most drug release and therefore, improved permeability and bioavailability of metformin.</p>

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8

M. S., Saygh, Uzunkaya G., Özsoy Y., and Araman A. "Enhanced Dissolution Rate of Tiaprofenic Acid Using Gelucire®44/14*." Scientia Pharmaceutica 70, no. 3 (2002): 295–307. http://dx.doi.org/10.3797/scipharm.aut-02-28.

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9

Chambin, O., and V. Jannin. "Interest of Multifunctional Lipid Excipients: Case of Gelucire® 44/14." Drug Development and Industrial Pharmacy 31, no. 6 (2005): 527–34. http://dx.doi.org/10.1080/03639040500215750.

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10

Mudrić, Jelena, Mirjana Pajić, Dubravka Bigović, and Jelena Ðuriš. "Development of gastroretentive floating granules with gentian root extract by hot-melt granulation." Lekovite sirovine, no. 40 (2020): 40–44. http://dx.doi.org/10.5937/leksir2040040m.

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The roots of yellow gentian, Gentiana lutea L. (Gentianaceae) are used in traditional medicine for the treatment of gastrointestinal disorders, with the literature data indicates a local gastric effect of gentian root extract (GRE) and support the use of the solid pharmaceutical forms. Gentiopicroside, as a dominant secoiridoid in the GRE, has a short elimination half-life and low bioavailability and, consequently, its bioactivity is limited. The aim of the study was to develop gastroretentive floating delivery system with GRE, and to provide prolonged release of gentiopicroside. Floating granules with dry GRE (DGRE) were prepared by the hot-melt granulation technique, while formulations included effervescent components (citric acid and sodium bicarbonate), hydroxypropyl methylcellulose (HPMC) and meltable binders (Compritol® 888 ATO and Gelucire® 50/13). The flowability of the DGRE and prepared formulations was determined by calculating the Carr index and Hausner ratio. Floating properties and in vitro dissolution rate of gentiopicroside from investigated formulations were examined. Floating granules were characterized with improved flowability (Carr index 14-22 %; Hausner ratio 1.16-1.28) in comparison to the DGRE (Carr index 28.99 %; Hausner ratio of 1.41). Furthermore, the floating granules exhibited immediate and long-lasting buoyancy and prolonged-release of gentiopicroside (over 8 h). Compritol® 888 ATO has provided sustained release of gentiopicroside from floating granules, while HPMC has decreased release rate additionally. On the other hand, Gelucire® 50/13 has increased gentiopicroside release rate. The results have shown that hot-melt granulation technique, as a green granulation method was successfully employed for obtaining gastroretentive floating granules with DGRE.

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11

Júlio, Ana, Anaisa Sultane, Ana Silveira Viana, Joana Portugal Mota, and Tânia Santos de Almeida. "Biobased Ionic Liquids as Multitalented Materials in Lipidic Drug Implants." Pharmaceutics 13, no. 8 (2021): 1163. http://dx.doi.org/10.3390/pharmaceutics13081163.

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Lipidic implants are valuable controlled delivery systems that present good biocompatibility and are useful for long-lasting therapies. However, these promising systems can present inflexible drug release profiles that limit their performance. Thus, finding new materials to overcome this drawback is crucial. Herein, lipidic implants containing caffeine and poorly soluble salicylic acid and rutin were developed. The inclusion of Gelucire® 50/02, sucrose, and two biobased ionic liquids, [Cho][Phe] and [Cho][Glu], were evaluated as a mean to improve the performance of the systems. The formulation procedure, dye content distribution, drug content, drug release, water content, and lipidic erosion of the developed systems were assessed. AFM analysis of the implants containing ILs was also performed. The results demonstrated that neither Gelucire® 50/02 nor sucrose were suitable tools to improve the drug release profile. In contrast, the ILs proved to be promising materials for multiple reasons; not only did they facilitate the formulation and incorporation of the studied drugs into the implants, but they also allowed a more suitable release profile, with [Cho][Glu] allowing a higher drug release due to its ability to increase surface wrinkling. Hence, this study showcases ILs as multitalented materials in lipid-based drug implants.

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12

Chauhan, Bhaskar, Shyam Shimpi, K. R. Mahadik, and Anant Paradkar. "Preparation and Evaluation of Floating Risedronate Sodium–Gelucire® 43/01 Formulations." Drug Development and Industrial Pharmacy 31, no. 9 (2005): 851–60. http://dx.doi.org/10.1080/03639040500271837.

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13

Lukovac, S., K. E. G. Gooijert, P. C. Gregory, et al. "Gelucire®44/14 improves fat absorption in rats with impaired lipolysis." Biochimica et Biophysica Acta (BBA) - Molecular and Cell Biology of Lipids 1801, no. 6 (2010): 665–73. http://dx.doi.org/10.1016/j.bbalip.2010.03.006.

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14

Shin, Dong, Bo Chae, Yoon Goo, et al. "Improved Dissolution and Oral Bioavailability of Valsartan Using a Solidified Supersaturable Self-Microemulsifying Drug Delivery System Containing Gelucire® 44/14." Pharmaceutics 11, no. 2 (2019): 58. http://dx.doi.org/10.3390/pharmaceutics11020058.

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To improve the dissolution and oral bioavailability of valsartan (VST), we previously formulated a supersaturable self-microemulsifying drug delivery system (SuSMED) composed of Capmul® MCM (oil), Tween® 80 (surfactant), Transcutol® P (cosurfactant), and Poloxamer 407 (precipitation inhibitor) but encountered a stability problem (Transcutol® P-induced weight loss in storage) after solidification. In the present study, replacing Transcutol® P with Gelucire® 44/14 resulted in a novel SuSMED formulation, wherein the total amount of surfactant/cosurfactant was less than that of the previous formulation. Solidified SuSMED (S-SuSMED) granules were prepared by blending VST-containing SuSMED with selective solid carriers, L-HPC and Florite® PS-10, wherein VST existed in an amorphous state. S-SuSMED tablets fabricated by direct compression with additional excipients were sufficiently stable in terms of drug content and impurity changes after 6 months of storage at accelerated conditions (40 ± 2 °C and 75 ± 5% relative humidity). Consequently, enhanced dissolution was obtained (pH 1.2, 2 h): 6-fold for S-SuSMED granules against raw VST; 2.3-fold for S-SuSMED tablets against Diovan® (reference tablet). S-SuSMED tablets increased oral bioavailability in rats (10 mg/kg VST dose): approximately 177–198% versus raw VST and Diovan®. Therefore, VST-loaded S-SuSMED formulations might be good candidates for practical development in the pharmaceutical industry.

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15

Al-Taani, Bashar, Mai S. Khanfar, Mutaz Sheikh Salem, and Alsayed Sallam. "Release behaviour of diclofenac sodium dispersed in Gelucire® and encapsulated with alginate beads." Journal of Microencapsulation 27, no. 1 (2010): 10–13. http://dx.doi.org/10.3109/02652040802586027.

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16

Fernandez, Sylvie, Jean-David Rodier, Nicolas Ritter, et al. "Lipolysis of the semi-solid self-emulsifying excipient Gelucire® 44/14 by digestive lipases." Biochimica et Biophysica Acta (BBA) - Molecular and Cell Biology of Lipids 1781, no. 8 (2008): 367–75. http://dx.doi.org/10.1016/j.bbalip.2008.05.006.

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17

Mehuys, E., C. Vervaet, and J. P. Remon. "Hot-melt extruded ethylcellulose cylinders containing a HPMC–Gelucire® core for sustained drug delivery." Journal of Controlled Release 94, no. 2-3 (2004): 273–80. http://dx.doi.org/10.1016/j.jconrel.2003.09.018.

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18

Mehuys, E., J. P. Remon, A. Korst, et al. "Human bioavailability of propranolol from a matrix-in-cylinder system with a HPMC-Gelucire® core." Journal of Controlled Release 107, no. 3 (2005): 523–36. http://dx.doi.org/10.1016/j.jconrel.2005.06.019.

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19

Ratsimbazafy, Voahirana, Evelyne Bourret, Roselyne Duclos, and Claude Brossard. "Rheological behavior of drug suspensions in Gelucire® mixtures and proxyphylline release from matrix hard gelatin capsules." European Journal of Pharmaceutics and Biopharmaceutics 48, no. 3 (1999): 247–52. http://dx.doi.org/10.1016/s0939-6411(99)00042-9.

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20

Fernandez, Sylvie, Stéphanie Chevrier, Nicolas Ritter, et al. "In Vitro Gastrointestinal Lipolysis of Four Formulations of Piroxicam and Cinnarizine with the Self Emulsifying Excipients Labrasol® and Gelucire® 44/14." Pharmaceutical Research 26, no. 8 (2009): 1901–10. http://dx.doi.org/10.1007/s11095-009-9906-2.

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21

Dubray, Océane, Vincent Jannin, Fréderic Demarne, Yann Pellequer, Alf Lamprecht, and Arnaud Béduneau. "In-vitro investigation regarding the effects of Gelucire ® 44/14 and Labrasol® ALF on the secretory intestinal transport of P-gp substrates." International Journal of Pharmaceutics 515, no. 1-2 (2016): 293–99. http://dx.doi.org/10.1016/j.ijpharm.2016.10.012.

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22

Trapani, Adriana, Giuseppe Tripodo, Delia Mandracchia, et al. "Glutathione-loaded solid lipid nanoparticles based on Gelucire® 50/13: Spectroscopic characterization and interactions with fish cells." Journal of Drug Delivery Science and Technology 47 (October 2018): 359–66. http://dx.doi.org/10.1016/j.jddst.2018.08.013.

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23

Jadhav, Snehal R., Gary Bryant, Jitendra P. Mata, et al. "Structural aspects of a self-emulsifying multifunctional amphiphilic excipient: Part I. The case of Gelucire® 44/14." Journal of Molecular Liquids 340 (October 2021): 117172. http://dx.doi.org/10.1016/j.molliq.2021.117172.

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24

Mura, Paola, Francesca Maestrelli, Mario D’Ambrosio, Cristina Luceri, and Marzia Cirri. "Evaluation and Comparison of Solid Lipid Nanoparticles (SLNs) and Nanostructured Lipid Carriers (NLCs) as Vectors to Develop Hydrochlorothiazide Effective and Safe Pediatric Oral Liquid Formulations." Pharmaceutics 13, no. 4 (2021): 437. http://dx.doi.org/10.3390/pharmaceutics13040437.

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The aim of this study was the optimization of solid lipid nanoparticles (SLN) and nanostructured lipid carriers (NLC) in terms of physicochemical and biopharmaceutical properties, to develop effective and stable aqueous liquid formulations of hydrochlorothiazide, suitable for paediatric therapy, overcoming its low-solubility and poor-stability problems. Based on solubility studies, Precirol® ATO5 and Transcutol® HP were used as solid and liquid lipids, respectively. The effect of different surfactants, also in different combinations and at different amounts, on particle size, homogeneity and surface-charge of nanoparticles was carefully investigated. The best formulations were selected for drug loading, and evaluated also for entrapment efficiency and release behaviour. For both SLN and NLC series, the use of Gelucire® 44/14 as surfactant rather than PluronicF68 or Tween® 80 yielded a marked particle size reduction (95–75 nm compared to around 600–400 nm), and an improvement in entrapment efficiency and drug release rate. NLC showed a better performance than SLN, reaching about 90% entrapped drug (vs. 80%) and more than 90% drug released after 300 min (vs. about 65%). All selected formulations showed good physical stability during 6-month storage at 4 °C, but a higher loss of encapsulated drug was found for SLNs (15%) than for NLCs (<5%). Moreover, all selected formulations revealed the absence of any cytotoxic effect, as assessed by a cell-viability test on Caco-2 cells and are able to pass the intestinal epithelium as suggested by Caco-2 uptake experiments.

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25

Damian, F., N. Blaton, R. Kinget, and G. Van den Mooter. "Physical stability of solid dispersions of the antiviral agent UC-781 with PEG 6000, Gelucire® 44/14 and PVP K30." International Journal of Pharmaceutics 244, no. 1-2 (2002): 87–98. http://dx.doi.org/10.1016/s0378-5173(02)00316-2.

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26

Lukovac, S., K. E. R. Gooijert, P. C. Gregory, et al. "Corrigendum to “Gelucire® 44/14 improves fat absorption in rats with impaired lipolysis” [Biochim. Biophys. Acta 1801 (2010) 665–673]." Biochimica et Biophysica Acta (BBA) - Molecular and Cell Biology of Lipids 1801, no. 9 (2010): 1105. http://dx.doi.org/10.1016/j.bbalip.2010.05.007.

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27

Ortiz, Andrea C., Osvaldo Yañez, Edison Salas-Huenuleo, and Javier O. Morales. "Development of a Nanostructured Lipid Carrier (NLC) by a Low-Energy Method, Comparison of Release Kinetics and Molecular Dynamics Simulation." Pharmaceutics 13, no. 4 (2021): 531. http://dx.doi.org/10.3390/pharmaceutics13040531.

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Lipid nanocarriers have a great potential for improving the physicochemical characteristics and behavior of poorly water-soluble drugs, such as aqueous dispersibility and oral bioavailability. This investigation presents a novel nanostructured lipid carrier (NLC) based on a mixture of solid lipid glycerides, fatty acid esters of PEG 1500 (Gelucire® 44/14), and an oil mix composed of capric and caprylic triglycerides (Miglyol® 812). These NLCs were developed by a simple low-energy method based on melt emulsification to yield highly encapsulating and narrowly distributed nanoparticles (~100 nm, PdI = 0.1, and zeta potential = ~−10 mV). Rhodamine 123 was selected as a poorly water-soluble drug model and owing to its spectroscopic properties. The novel NLCs were characterized by dynamic light scattering (DLS), zeta potential, nanoparticle tracking analysis (NTA), transmission electron microscopy (TEM), differential scanning calorimetry (DSC), and colloidal stability. The drug release was determined through a dialysis bag and vertical Franzs’ cells to provide insights about the methods’ suitability, revealing similar performance regardless of their different fluid dynamics. Rhodamine 123 followed a characteristic biphasic release profile owing to the swelling of the hydrophilic polymer coating and diffusion process from the lipid core as revealed by the Korsmeyers–Peppas kinetic modeling. Moreover, to elucidate the formation and incorporation of Rhodamine 123 into the NLC core, several molecular dynamics simulations were conducted. The temperature was shown to be an important condition to improve the formation of the nanoparticles. In addition, the liquid lipid incorporation to the formulation forms nanoparticles with imperfect centers, in contrast to nanoparticles without it. Moreover, Miglyol® 812 improves hydrophobic molecule solubility. These results suggest the potential of novel NLC as a drug delivery system for poorly water-soluble drugs.

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28

Albertini, Beatrice, Beatrice Perissutti, Serena Bertoni, et al. "Combining Mechanochemistry and Spray Congealing for New Praziquantel Pediatric Formulations in Schistosomiasis Treatment." International Journal of Molecular Sciences 20, no. 5 (2019): 1233. http://dx.doi.org/10.3390/ijms20051233.

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Praziquantel (PZQ) is the first line drug for the treatment of schistosome infections and is included in the WHO Model List of Essential Medicines for Children. In this study, the association of mechanochemical activation (MA) and the spray congealing (SC) technology was evaluated for developing a child-friendly PZQ dosage form, with better product handling and biopharmaceutical properties, compared to MA materials. A 1:1 by wt PZQ—Povidone coground—was prepared in a vibrational mill under cryogenic conditions, for favoring amorphization. PZQ was neat ground to obtain its polymorphic form (Form B), which has an improved solubility and bioactivity. Then, activated PZQ powders were loaded into microparticles (MPs) by the SC technology, using the self-emulsifying agent Gelucire® 50/13 as a carrier. Both, the activated powders and the corresponding loaded MPs were characterized for morphology, wettability, solubility, dissolution behavior, drug content, and drug solid state (Hot Stage Microscopy (HSM), Differential Scanning Calorimetry (DSC), X-Ray Powder Diffraction Studies (PXRD), and FT-IR). Samples were also in vitro tested for a comparison with PZQ against Schistosoma mansoni newly transformed schistosomula (NTS) and adults. MPs containing both MA systems showed a further increase of biopharmaceutical properties, compared to the milled powders, while maintaining PZQ bioactivity. MPs containing PZQ Form B represented the most promising product for designing a new PZQ formulation.

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29

Koga, Kenjiro, Susumu Kawashima, and Masahiro Murakami. "In vitro and in situ evidence for the contribution of Labrasol® and Gelucire 44/14 on transport of cephalexin and cefoperazone by rat intestine." European Journal of Pharmaceutics and Biopharmaceutics 54, no. 3 (2002): 311–18. http://dx.doi.org/10.1016/s0939-6411(02)00116-9.

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30

Perteghella, Sara, Delia Mandracchia, Maria Luisa Torre, et al. "Anti-angiogenic activity of uncoated- and N,O-carboxymethyl-chitosan surface modified-Gelucire® 50/13 based solid lipid nanoparticles for oral delivery of curcumin." Journal of Drug Delivery Science and Technology 56 (April 2020): 101494. http://dx.doi.org/10.1016/j.jddst.2019.101494.

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31

El-Mancy, Shereen S., Alaadin E. El-Haddad, Walaa A. Alshareef, Amr M. Saadeldeen, Soad Z. El-Emam, and Osama S. Elnahas. "Enhancement of Antimicrobial and Antiproliferative Activities of Standardized Frankincense Extract Using Optimized Self-Nanoemulsifying Delivery System." Scientia Pharmaceutica 89, no. 3 (2021): 36. http://dx.doi.org/10.3390/scipharm89030036.

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Boswellic acids (BAs) are the main bioactive compounds of frankincense, a natural resin obtained from the genus Boswellia. This study aimed to develop a self-nanoemulsifying delivery system (SNEDS) to improve the antimicrobial and antiproliferative activities of standardized frankincense extract (Fr-extract). Fr-extract was standardized, and BA content was quantified using the developed HPLC-UV method. Screening studies of excipients followed by formula optimization using a mixture simplex lattice design was employed. The optimized Fr-SENDS formulation was characterized. Furthermore, microbiological and antiproliferative assessments of the standardized Fr-extract and Fr-SNEDS were evaluated. Quantification demonstrated that the major constituent is 11-keto-boswellic acid (KBA) (16.25%) among BA content (44.96%). The optimized Fr-SENDS (composed of 5% CapryolTM 90, 48.7% Gelucire® 44/14 and 46.3% ethanol) showed spherical nanosized dispersions with DS, PDI, and zeta potential of 17.9 nm, 0.2, and −14.5 mV, respectively. Fr-SNEDS exhibited lower MIC and MBC values compared with Fr-extract against pathogens conjugated with lung cancer and was comparable to reference antimicrobials. Fr-SNEDS showed superior antiproliferative activity over Fr-extract, with IC50 values of 20.49 and 109.5 μg mL−1, respectively. In conclusion, the optimized Fr-SNEDS could be easily developed and manufactured at a low cost and the in vitro results support its use as a potential adjuvant oral therapy for lung cancer. Further in vivo studies could be continued to assess the therapeutic efficiency of the prepared system.

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32

Reginald-Opara, J. N., K. C. Ofokansi, F. C. Kenechukwu, C. G. Nwaigwe, and A. M. Nnogo. "Controlled Release Binary and Ternary HPMC-HPC-Gelucire® 50/13 Hybrids Based Solid Dispersions of Indomethacin: In vitro Evaluation and In vivo Anti-inflammatory Studies." Journal of Pharmaceutical Research International 24, no. 1 (2018): 1–12. http://dx.doi.org/10.9734/jpri/2018/22643.

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33

Al-Taani, Bashar, Mai Khanfar, Mutaz Sheikh Salem, and Alsayed Sallam. "Release behaviour of diclofenac sodium dispersed in Gelucire® and encapsulated with alginate beads." Journal of Microencapsulation, December 3, 2008, 1–4. http://dx.doi.org/10.1080/02652040802586027.

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34

Surawase, Rajendra K., and Kamalkishor G. Baheti. "Solid Dispersion by Fluidized Bed Processing: A Platform for Enhancement of Dissolution Rate of Simvastatin Poorly Water-Soluble Drug." Journal of Pharmaceutical Research International, August 25, 2021, 32–43. http://dx.doi.org/10.9734/jpri/2021/v33i42a32381.

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Aim: The aim of this study was to study the solubility and dissolution kinetics of poorly water-soluble drugs simvastatin from its solid dispersion with different carriers by using fluidized bed processing technique. Methods: The effect of different surfactants such as Gelucire® 44/14, PVP- K30 and Poloxamer- 188 on solid dispersion dissolution and solubility of simvastatin was investigated. Solid dispersion is formed using various techniques with polymeric carrier to potentially enhance the solubility and dissolution rate such as fluidized bed processing, it will extend drug absorption, therefore the objectives were to make a comparative evaluation among different solid dispersions. Results: The simvastatin solid dispersion prepared by fluidized bed processing significantly enhanced in vitro dissolution and solubility relative to that of the unprocessed form. The dissolution profiles were correlated using various mathematical models such as Zero order, first order, Higuchi and Hixon Crowell model and the Zero order kinetics model gave better correlation results than the other models. Conclusion: Dissolution profile of simvastatin was significantly improved via complexation with Gelucire 44/14 as compared with the pure drug and other carriers using FBP processing is a highly effective strategy for enhancing the solubility and dissolution of poorly water-soluble drugs.

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Aldosari, Basmah N., Alanood S. Almurshedi, Iman M. Alfagih, et al. "Formulation of Gelucire®-Based Solid Dispersions of Atorvastatin Calcium: In Vitro Dissolution and In Vivo Bioavailability Study." AAPS PharmSciTech 22, no. 5 (2021). http://dx.doi.org/10.1208/s12249-021-02019-5.

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Shinde, Umesh K., Dilipkumar G. Suryawanshi, and Purnima D. Amin. "Development of Gelucire® 48/16 and TPGS Mixed Micelles and Its Pellet Formulation by Extrusion Spheronization Technique for Dissolution Rate Enhancement of Curcumin." AAPS PharmSciTech 22, no. 5 (2021). http://dx.doi.org/10.1208/s12249-021-02032-8.

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