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Development and Evaluation of Mouth Dissolving Films of Amlodipine Besylate for Enhanced Therapeutic Efficacy.

Maheswari KM, Devineni PK, Deekonda S, Shaik S, Uppala NP, Nalluri BN - J Pharm (Cairo) (2014)

Bottom Line: MDFs with PVP K30 and SLS gave superior dissolution properties when compared to MDFs without PVP K30 and SLS.The dissolution properties of MDFs with PVP K30 were superior when compared to MDFs with SLS.In the case of F3 containing 7.5% of HPMC E3 and 0.04% of PVP K30, complete and faster release was observed within 60 sec when compared to other formulations.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada, Andhra Pradesh 520010, India.

ABSTRACT
The present investigation was undertaken with an objective of formulating mouth dissolving films (MDFs) of Amlodipine Besylate (AMLO) to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy. Film formers like hydroxy propyl methyl cellulose (HPMC) and methyl cellulose (MC) along with film modifiers like poly vinyl pyrrolidone K30 (PVP K30), and sodium lauryl sulphate (SLS) as solubilizing agents were evaluated. The prepared MDFs were evaluated for in vitro dissolution characteristics, in vitro disintegration time, and their physicomechanical properties. All the prepared MDFs showed good mechanical properties like tensile strength, folding endurance, and % elongation. MDFs were evaluated by means of FTIR, SEM, and X-RD studies. MDFs with 7.5% (w/w) of HPMC E3 gave better dissolution properties when compared to HPMC E5, HPMC E15, and MC. MDFs with PVP K30 and SLS gave superior dissolution properties when compared to MDFs without PVP K30 and SLS. The dissolution properties of MDFs with PVP K30 were superior when compared to MDFs with SLS. In the case of F3 containing 7.5% of HPMC E3 and 0.04% of PVP K30, complete and faster release was observed within 60 sec when compared to other formulations. Release kinetics data reveals diffusion is the release mechanism.

No MeSH data available.


Related in: MedlinePlus

Dissolution setup assembly.
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fig1: Dissolution setup assembly.

Mentions: The in vitro dissolution studies were conducted using 500 mL of artificial saliva as dissolution medium with modified type 5 dissolution apparatus. A temperature of 37°C and 50 rpm was used. Each film with a dimension of appropriate size equivalent to 5 mg of AMLO was placed on a watch glass covered with nylon wire mesh as shown in Figure 1. The watch glass was then dropped into a dissolution flask. Five mL samples were withdrawn at 10, 20, 30, 40, 50, 60, 80, 100, and 120 sec time intervals and every time replaced with 5 mL of fresh dissolution medium. The samples were analyzed by measuring absorbance at 238 nm. The dissolution experiments were conducted in triplicate.


Development and Evaluation of Mouth Dissolving Films of Amlodipine Besylate for Enhanced Therapeutic Efficacy.

Maheswari KM, Devineni PK, Deekonda S, Shaik S, Uppala NP, Nalluri BN - J Pharm (Cairo) (2014)

Dissolution setup assembly.
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4590810&req=5

fig1: Dissolution setup assembly.
Mentions: The in vitro dissolution studies were conducted using 500 mL of artificial saliva as dissolution medium with modified type 5 dissolution apparatus. A temperature of 37°C and 50 rpm was used. Each film with a dimension of appropriate size equivalent to 5 mg of AMLO was placed on a watch glass covered with nylon wire mesh as shown in Figure 1. The watch glass was then dropped into a dissolution flask. Five mL samples were withdrawn at 10, 20, 30, 40, 50, 60, 80, 100, and 120 sec time intervals and every time replaced with 5 mL of fresh dissolution medium. The samples were analyzed by measuring absorbance at 238 nm. The dissolution experiments were conducted in triplicate.

Bottom Line: MDFs with PVP K30 and SLS gave superior dissolution properties when compared to MDFs without PVP K30 and SLS.The dissolution properties of MDFs with PVP K30 were superior when compared to MDFs with SLS.In the case of F3 containing 7.5% of HPMC E3 and 0.04% of PVP K30, complete and faster release was observed within 60 sec when compared to other formulations.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutics, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada, Andhra Pradesh 520010, India.

ABSTRACT
The present investigation was undertaken with an objective of formulating mouth dissolving films (MDFs) of Amlodipine Besylate (AMLO) to enhance convenience and compliance of the elderly and pediatric patients for better therapeutic efficacy. Film formers like hydroxy propyl methyl cellulose (HPMC) and methyl cellulose (MC) along with film modifiers like poly vinyl pyrrolidone K30 (PVP K30), and sodium lauryl sulphate (SLS) as solubilizing agents were evaluated. The prepared MDFs were evaluated for in vitro dissolution characteristics, in vitro disintegration time, and their physicomechanical properties. All the prepared MDFs showed good mechanical properties like tensile strength, folding endurance, and % elongation. MDFs were evaluated by means of FTIR, SEM, and X-RD studies. MDFs with 7.5% (w/w) of HPMC E3 gave better dissolution properties when compared to HPMC E5, HPMC E15, and MC. MDFs with PVP K30 and SLS gave superior dissolution properties when compared to MDFs without PVP K30 and SLS. The dissolution properties of MDFs with PVP K30 were superior when compared to MDFs with SLS. In the case of F3 containing 7.5% of HPMC E3 and 0.04% of PVP K30, complete and faster release was observed within 60 sec when compared to other formulations. Release kinetics data reveals diffusion is the release mechanism.

No MeSH data available.


Related in: MedlinePlus