Abstract
Orodispersible film is the type of drug delivery systems which when placed in the oral cavity disintegrates or dissolves within few seconds without water intake. This type of technology offer a convenient alternative way of dosing medication, not to special population groups, but also to the general population. The present investigation highlights on the formulation and evaluation of orodispersible films of poorly soluble antiepileptic drug lamotrigine. Dissolution characteristics of the drug was improved by forming inclusion complexes with hydroxypropyl β‐cyclodextrin (HPβCD) employing co-evaporation technique and the complexes were characterized by differential scanning calorimetry (DSC) and fourier transformation infrared spectroscopy (FTIR). Orodispersible films of LMN-HPβCD (1:1) were prepared by the solvent-casting method; using water soluble film forming polymers such as hydroxyl propyl methyl cellulose (HPMC15), polyvinyl alcohol (PVA) and Sodium carboxy methyl cellulose (SCMC).Propylene glycol and glycerin were used as plasticizers. The prepared films were evaluated for their physicochemical characteristics such as appearance, thickness, folding endurance, drug content uniformity, surface pH, disintegration time and mechanical properties, in vitro drug release and stability studies were performed for the optimized formula according to the ICH guideline under 40°C/75% RH for three months. Amongst all formulations F2 films prepared with1% w/v PVA plasticized with 3% glycerin was considered as the optimized formulation, it has the highest drug release, satisfactory in vitro disintegration time, tensile strength, % elongation, folding endurance and stable formula. Overall results suggest that PVA is an excellent film former for antiepileptic drug lamotrigine. Therefore, orodispersible films is considered to be potentially suitable for the immediate release whenever required of lamotrigine to improve patient compliance.
Highlights
A drug can be administered via many different routes to produce a systemic pharmacologic effect
Lamotrigine is an antiepileptic agent shown to be effective in adjunctive treatment for refractory partial seizures and generalized seizures.It is very slightly soluble in water (0.17 mg/ml at 25°C) with a bitter taste [3], improvement of drug dissolution is desirable to improve the bioavailability of poorly water soluble drug .Among the various techniques used for the improvement in the drug dissolution characteristics, inclusion complexation with HPβ-CD utilizing the co evaporation technique [4]
The intraoral rout is preferred over many other routs for easy of administration and sudden-onset of drug action is possible .Fast dissolving drug delivery systems have started gaining popularity and acceptance as relatively new drug delivery systems, because they are easy to administer and lead to better patient compliance.These delivery systems either dissolve or disintegrate in the mouth rapidly, without requiring any water to aid in swallowing, releasing the active drug
Summary
A drug can be administered via many different routes to produce a systemic pharmacologic effect. The intraoral rout is preferred over many other routs for easy of administration and sudden-onset of drug action is possible .Fast dissolving drug delivery systems have started gaining popularity and acceptance as relatively new drug delivery systems, because they are easy to administer and lead to better patient compliance.These delivery systems either dissolve or disintegrate in the mouth rapidly, without requiring any water to aid in swallowing, releasing the active drug They are useful in patients[5,6,7]such as pediatric, geriatric, bedridden,or developmentally disabled,who may face difficulty in swallowing conventional tablets or capsules and liquid orals or syrup, leading to ineffective therapy [8] .Due to the large surface area of the buccal mucosa being highly vascularized, drugs can be absorbed directly and can enter the systemic circulation without undergoing first‐pass hepatic metabolism and obtain rapid onset of action. The objective of the present study was to improve the aqueous solubility and dissolution rate of poorly soluble lamotrigine by inclusion complexation and formulate orodispersible films of LMN-HPβCD co-evaporate using different concentration of different water soluble film forming polymers such as hydroxyl propyl methyl cellulose (HPMC) ,poly vinyl alcohol (PVA)and NaCMC and clarify the effect of different plasticizers such as propylene glycol (PG) and glycerin
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