The Experts below are selected from a list of 96 Experts worldwide ranked by ideXlab platform
L Montanari - One of the best experts on this subject based on the ideXlab platform.
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Diclofenac fast dissolving film: suppression of bitterness by a taste-sensing system
2012Co-Authors: F. Cilurzo, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Fast-dissolving oral delivery systems are solid dosage forms which disintegrate or dissolve rapidly (< 1 min) when placed in the mouth, without drinking or chewing (tablets and films). As forming materials, maltodextrins (MDX) plasticized by glycerin were recently proposed to produce fast-dissolving films by solvent casting and hot-melt extrusion (Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. (2008). Fast dissolving films made of maltodextrins. Eur. J Pharm Biopharm, 70(3), 895-900). In the development of orodispersible films, the main critical issues are represented by the tensile properties required for packaging and handling procedures, dissolution in the oral cavity, stability and taste. Generally speaking, organoleptic characteristics are important parameters which drive patients\u2019 acceptance and compliance and, taste is one of the prime factors determining the market penetration and commercial success of oral pharmaceuticals. The development of more desirable and palatable formulations often represents a challenge for pharmaceutical companies, which are currently investing time and costs in the study of taste-masking techniques. The selection of a proper taste masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs since, compared to conventional liquid dosage forms, active ingredient is not diluted and the TMA amounts are limited with respect to orodispersible tablets due to the low weight of the film. This work aimed to evaluate the suppression of the bitter taste of a maltodextrin (MDX) fast dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Films were prepared by casting and drying aqueous mixtures of MDX (DE = 6), glycerin, Sorbitan Oleate and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue (ET). The addition of mint flavour or liquorice flavour improved the taste of the DS-sucralose solutions and resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. By considering the sensory panel, sucralose-mint-liquorice solution appeared the most suitable combination to mask the DS taste. All films appeared homogeneous upon a visual inspection, flexible and not brittle. They were handled, cut and packed without occurring failure. The films weighted in the 95-110 mg range and the DS content complied the drug content assay according to the Ph. Eur. and was consistent with the theoretic drug loading, namely 13.4 mg. The addition of the selected TMAs did not significantly affect film disintegration time (15-20 s) and DS dissolution rate (about 5 min). The taste sensor system, i.e. electronic tongue, represents a useful tool to evaluate the feasibility to suppress the drug bitterness by TMAs during the development of fast-dissolving films. This system can allow discriminating the effect of the TMA also in presence of the other hydrosoluble constituents, namely polymers and surfactants. Since ET presents the advantages of simplicity and rapidity, this technique could assist, or even replace, the sensory evaluation in the development of new pharmaceutical formulations providing information about the taste without the need of humans to taste active compounds
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:CONTEXT: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs. OBJECTIVE: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. METHODS: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. RESULTS: The 'mint' and 'licorice' flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15-20 seconds) and DS dissolution rate (about 5 minutes). CONCLUSION: The electronic tongue was allowed to discriminate the effect of the TMA also in the presence of other hydrosoluble constituents of the film. Therefore, because of its simplicity and rapidity, this technique could assist or even replace the sensory evaluation in the development of fast-dissolving films.
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Context: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast‐dissolving films containing bitter drugs. Objective: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Methods: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. Results: The ‘mint’ and ‘licorice’ flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15–20 seconds) and DS dissolution rate (about 5 minutes). Conclusion: The electronic tongue was allowed t...
Francesco Cilurzo - One of the best experts on this subject based on the ideXlab platform.
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:CONTEXT: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs. OBJECTIVE: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. METHODS: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. RESULTS: The 'mint' and 'licorice' flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15-20 seconds) and DS dissolution rate (about 5 minutes). CONCLUSION: The electronic tongue was allowed to discriminate the effect of the TMA also in the presence of other hydrosoluble constituents of the film. Therefore, because of its simplicity and rapidity, this technique could assist or even replace the sensory evaluation in the development of fast-dissolving films.
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Context: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast‐dissolving films containing bitter drugs. Objective: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Methods: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. Results: The ‘mint’ and ‘licorice’ flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15–20 seconds) and DS dissolution rate (about 5 minutes). Conclusion: The electronic tongue was allowed t...
P Minghetti - One of the best experts on this subject based on the ideXlab platform.
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Olanzapine orodispersible films: the impact of preparation method on drug dissolution
2019Co-Authors: G.m. Khalid, P Minghetti, U.m. Musazzi, F. Selmin, F. CilurzoAbstract:Background: Olanzapine (OLZ) can take the advantage of administration as orodispersible films (ODF) to improve adherence in psychiatric patients as ODF disintegrate quickly in the mouth without need of water. ODF can be prepared by solvent-casting or extrusion-based technologies. However, the preparation method needs to be carefully selected since water can influence the OLZ solid state and, consequently, the drug dissolution properties. Purpose: This study aims to compare the OLZ dissolution from ODF obtained by an aqueous-based solvent casting and a novel hot-melt ram-extrusion 3D printing. Methods: The ODF were prepared by casting and drying aqueous slurry of OLZ, maltodextrin (DE = 6), glycerine and Sorbitan Oleate; while the hot-melt ram-extrusion 3D ODF were obtained by printing a paste containing OLZ, maltodextrins (DE=6) plasticized with glycerine. In each case, 10 mg OLZ was loaded in 6 cm2 ODF. ODF were characterized for thickness, loss on drying, disintegration time and in vitro dissolution in deionized water. Results: ODF appeared homogeneous and easy to handle without cracks. The cast and printed ODF thicknesses were 140±4.5 μm and 278±13.2 µm respectively. Residual water content in ODF was in the 6-8% w/w range. In both cases, ODF disintegrated within 60 s, complying the Pharmacopeia specifications. For in vitro dissolution, about 90% OLZ was released in 3 min for the 3D printed films; in contrast, an erratic drug release was observed for the OLZ ODF made by casting with a concomitant formation of a yellow precipitate after 3 min, which suggest a change in the OLZ solid state. Conclusion: The solvent-free hot melt ram extrusion 3D printing technique can be suitable for ODF preparation for drugs sensitive to solvent system
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Olanzapine orodispersible films: the impact of preparation method on drug dissolution
2019Co-Authors: G.m. Khalid, P Minghetti, U.m. Musazzi, F. Selmin, F. CilurzoAbstract:Background: Olanzapine (OLZ) can take the advantage of administration as orodispersible films (ODF) to improve adherence in psychiatric patients as ODF disintegrate quickly in the mouth without need of water. ODF can be prepared by solvent-casting or extrusion-based technologies. However, the preparation method needs to be carefully selected since water can influence the OLZ solid state and, consequently, the drug dissolution properties. Purpose: This study aims to compare the OLZ dissolution from ODF obtained by an aqueous-based solvent casting and a novel hot-melt ram-extrusion 3D printing. Methods: The ODF were prepared by casting and drying aqueous slurry of OLZ, maltodextrin (DE = 6), glycerine and Sorbitan Oleate; while the hot-melt ram-extrusion 3D ODF were obtained by printing a paste containing OLZ, maltodextrins (DE=6) plasticized with glycerine. In each case, 10 mg OLZ was loaded in 6 cm2 ODF. ODF were characterized for thickness, loss on drying, disintegration time and in vitro dissolution in deionized water. Results: ODF appeared homogeneous and easy to handle without cracks. The cast and printed ODF thicknesses were 140\ub14.5 \u3bcm and 278\ub113.2 \ub5m respectively. Residual water content in ODF was in the 6-8% w/w range. In both cases, ODF disintegrated within 60 s, complying the Pharmacopeia specifications. For in vitro dissolution, about 90% OLZ was released in \uf07e3 min for the 3D printed films; in contrast, an erratic drug release was observed for the OLZ ODF made by casting with a concomitant formation of a yellow precipitate after 3 min, which suggest a change in the OLZ solid state. Conclusion: The solvent-free hot melt ram extrusion 3D printing technique can be suitable for ODF preparation for drugs sensitive to solvent system
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Diclofenac fast dissolving film: suppression of bitterness by a taste-sensing system
2012Co-Authors: F. Cilurzo, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Fast-dissolving oral delivery systems are solid dosage forms which disintegrate or dissolve rapidly (< 1 min) when placed in the mouth, without drinking or chewing (tablets and films). As forming materials, maltodextrins (MDX) plasticized by glycerin were recently proposed to produce fast-dissolving films by solvent casting and hot-melt extrusion (Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. (2008). Fast dissolving films made of maltodextrins. Eur. J Pharm Biopharm, 70(3), 895-900). In the development of orodispersible films, the main critical issues are represented by the tensile properties required for packaging and handling procedures, dissolution in the oral cavity, stability and taste. Generally speaking, organoleptic characteristics are important parameters which drive patients\u2019 acceptance and compliance and, taste is one of the prime factors determining the market penetration and commercial success of oral pharmaceuticals. The development of more desirable and palatable formulations often represents a challenge for pharmaceutical companies, which are currently investing time and costs in the study of taste-masking techniques. The selection of a proper taste masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs since, compared to conventional liquid dosage forms, active ingredient is not diluted and the TMA amounts are limited with respect to orodispersible tablets due to the low weight of the film. This work aimed to evaluate the suppression of the bitter taste of a maltodextrin (MDX) fast dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Films were prepared by casting and drying aqueous mixtures of MDX (DE = 6), glycerin, Sorbitan Oleate and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue (ET). The addition of mint flavour or liquorice flavour improved the taste of the DS-sucralose solutions and resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. By considering the sensory panel, sucralose-mint-liquorice solution appeared the most suitable combination to mask the DS taste. All films appeared homogeneous upon a visual inspection, flexible and not brittle. They were handled, cut and packed without occurring failure. The films weighted in the 95-110 mg range and the DS content complied the drug content assay according to the Ph. Eur. and was consistent with the theoretic drug loading, namely 13.4 mg. The addition of the selected TMAs did not significantly affect film disintegration time (15-20 s) and DS dissolution rate (about 5 min). The taste sensor system, i.e. electronic tongue, represents a useful tool to evaluate the feasibility to suppress the drug bitterness by TMAs during the development of fast-dissolving films. This system can allow discriminating the effect of the TMA also in presence of the other hydrosoluble constituents, namely polymers and surfactants. Since ET presents the advantages of simplicity and rapidity, this technique could assist, or even replace, the sensory evaluation in the development of new pharmaceutical formulations providing information about the taste without the need of humans to taste active compounds
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:CONTEXT: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs. OBJECTIVE: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. METHODS: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. RESULTS: The 'mint' and 'licorice' flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15-20 seconds) and DS dissolution rate (about 5 minutes). CONCLUSION: The electronic tongue was allowed to discriminate the effect of the TMA also in the presence of other hydrosoluble constituents of the film. Therefore, because of its simplicity and rapidity, this technique could assist or even replace the sensory evaluation in the development of fast-dissolving films.
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Context: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast‐dissolving films containing bitter drugs. Objective: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Methods: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. Results: The ‘mint’ and ‘licorice’ flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15–20 seconds) and DS dissolution rate (about 5 minutes). Conclusion: The electronic tongue was allowed t...
Chiara G M Gennari - One of the best experts on this subject based on the ideXlab platform.
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Diclofenac fast dissolving film: suppression of bitterness by a taste-sensing system
2012Co-Authors: F. Cilurzo, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Fast-dissolving oral delivery systems are solid dosage forms which disintegrate or dissolve rapidly (< 1 min) when placed in the mouth, without drinking or chewing (tablets and films). As forming materials, maltodextrins (MDX) plasticized by glycerin were recently proposed to produce fast-dissolving films by solvent casting and hot-melt extrusion (Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. (2008). Fast dissolving films made of maltodextrins. Eur. J Pharm Biopharm, 70(3), 895-900). In the development of orodispersible films, the main critical issues are represented by the tensile properties required for packaging and handling procedures, dissolution in the oral cavity, stability and taste. Generally speaking, organoleptic characteristics are important parameters which drive patients\u2019 acceptance and compliance and, taste is one of the prime factors determining the market penetration and commercial success of oral pharmaceuticals. The development of more desirable and palatable formulations often represents a challenge for pharmaceutical companies, which are currently investing time and costs in the study of taste-masking techniques. The selection of a proper taste masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs since, compared to conventional liquid dosage forms, active ingredient is not diluted and the TMA amounts are limited with respect to orodispersible tablets due to the low weight of the film. This work aimed to evaluate the suppression of the bitter taste of a maltodextrin (MDX) fast dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Films were prepared by casting and drying aqueous mixtures of MDX (DE = 6), glycerin, Sorbitan Oleate and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue (ET). The addition of mint flavour or liquorice flavour improved the taste of the DS-sucralose solutions and resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. By considering the sensory panel, sucralose-mint-liquorice solution appeared the most suitable combination to mask the DS taste. All films appeared homogeneous upon a visual inspection, flexible and not brittle. They were handled, cut and packed without occurring failure. The films weighted in the 95-110 mg range and the DS content complied the drug content assay according to the Ph. Eur. and was consistent with the theoretic drug loading, namely 13.4 mg. The addition of the selected TMAs did not significantly affect film disintegration time (15-20 s) and DS dissolution rate (about 5 min). The taste sensor system, i.e. electronic tongue, represents a useful tool to evaluate the feasibility to suppress the drug bitterness by TMAs during the development of fast-dissolving films. This system can allow discriminating the effect of the TMA also in presence of the other hydrosoluble constituents, namely polymers and surfactants. Since ET presents the advantages of simplicity and rapidity, this technique could assist, or even replace, the sensory evaluation in the development of new pharmaceutical formulations providing information about the taste without the need of humans to taste active compounds
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:CONTEXT: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs. OBJECTIVE: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. METHODS: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. RESULTS: The 'mint' and 'licorice' flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15-20 seconds) and DS dissolution rate (about 5 minutes). CONCLUSION: The electronic tongue was allowed to discriminate the effect of the TMA also in the presence of other hydrosoluble constituents of the film. Therefore, because of its simplicity and rapidity, this technique could assist or even replace the sensory evaluation in the development of fast-dissolving films.
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Context: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast‐dissolving films containing bitter drugs. Objective: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Methods: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. Results: The ‘mint’ and ‘licorice’ flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15–20 seconds) and DS dissolution rate (about 5 minutes). Conclusion: The electronic tongue was allowed t...
S Buratti - One of the best experts on this subject based on the ideXlab platform.
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Diclofenac fast dissolving film: suppression of bitterness by a taste-sensing system
2012Co-Authors: F. Cilurzo, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Fast-dissolving oral delivery systems are solid dosage forms which disintegrate or dissolve rapidly (< 1 min) when placed in the mouth, without drinking or chewing (tablets and films). As forming materials, maltodextrins (MDX) plasticized by glycerin were recently proposed to produce fast-dissolving films by solvent casting and hot-melt extrusion (Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. (2008). Fast dissolving films made of maltodextrins. Eur. J Pharm Biopharm, 70(3), 895-900). In the development of orodispersible films, the main critical issues are represented by the tensile properties required for packaging and handling procedures, dissolution in the oral cavity, stability and taste. Generally speaking, organoleptic characteristics are important parameters which drive patients\u2019 acceptance and compliance and, taste is one of the prime factors determining the market penetration and commercial success of oral pharmaceuticals. The development of more desirable and palatable formulations often represents a challenge for pharmaceutical companies, which are currently investing time and costs in the study of taste-masking techniques. The selection of a proper taste masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs since, compared to conventional liquid dosage forms, active ingredient is not diluted and the TMA amounts are limited with respect to orodispersible tablets due to the low weight of the film. This work aimed to evaluate the suppression of the bitter taste of a maltodextrin (MDX) fast dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Films were prepared by casting and drying aqueous mixtures of MDX (DE = 6), glycerin, Sorbitan Oleate and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue (ET). The addition of mint flavour or liquorice flavour improved the taste of the DS-sucralose solutions and resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. By considering the sensory panel, sucralose-mint-liquorice solution appeared the most suitable combination to mask the DS taste. All films appeared homogeneous upon a visual inspection, flexible and not brittle. They were handled, cut and packed without occurring failure. The films weighted in the 95-110 mg range and the DS content complied the drug content assay according to the Ph. Eur. and was consistent with the theoretic drug loading, namely 13.4 mg. The addition of the selected TMAs did not significantly affect film disintegration time (15-20 s) and DS dissolution rate (about 5 min). The taste sensor system, i.e. electronic tongue, represents a useful tool to evaluate the feasibility to suppress the drug bitterness by TMAs during the development of fast-dissolving films. This system can allow discriminating the effect of the TMA also in presence of the other hydrosoluble constituents, namely polymers and surfactants. Since ET presents the advantages of simplicity and rapidity, this technique could assist, or even replace, the sensory evaluation in the development of new pharmaceutical formulations providing information about the taste without the need of humans to taste active compounds
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:CONTEXT: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast-dissolving films containing bitter drugs. OBJECTIVE: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. METHODS: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. RESULTS: The 'mint' and 'licorice' flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15-20 seconds) and DS dissolution rate (about 5 minutes). CONCLUSION: The electronic tongue was allowed to discriminate the effect of the TMA also in the presence of other hydrosoluble constituents of the film. Therefore, because of its simplicity and rapidity, this technique could assist or even replace the sensory evaluation in the development of fast-dissolving films.
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diclofenac fast dissolving film suppression of bitterness by a taste sensing system
Drug Development and Industrial Pharmacy, 2011Co-Authors: Francesco Cilurzo, I E Cupone, P Minghetti, S Buratti, Chiara G M Gennari, L MontanariAbstract:Context: The selection of a proper taste-masking agent (TMA) is a critical issue in the development of fast‐dissolving films containing bitter drugs. Objective: This work is aimed to evaluate the suppression of the bitter taste of a maltodextrin fast-dissolving film loaded with 13.4 mg sodium diclofenac (DS) by adding TMAs. Methods: The films were prepared by casting and drying aqueous mixtures of maltodextrin (DE = 6), glycerin, Sorbitan Oleate, and DS. Films were characterized in terms of thickness, tensile properties, film disintegration time, and drug dissolution time. The bitterness intensity of DS and the masking effect of TMAs were evaluated by an electronic tongue. Results: The ‘mint’ and ‘licorice’ flavors and sucralose mixture resulted appropriate to mask DS bitterness as confirmed by a panel of volunteers. The addition of these TMAs did not significantly affect the film disintegration time (15–20 seconds) and DS dissolution rate (about 5 minutes). Conclusion: The electronic tongue was allowed t...