Abstract

FORMULATION AND INVITRO CHARACTERIZATION OF AMITRIPTYLINE BUCCAL FILMS

Krishnaveni Manubolu*, Abbineni Venkata Chandana, Pasupuleti Prakash,Byna Sujatha, Somavarapu Usha Rani, Karnati Venkata Radhika

ABSTRACT

Oral drug delivery is the most preferable route of drug administration due to ease of administration, patient compliance, flexibility in formulation. Buccal drug delivery system which is painless, without discomfort, precise dosage form, facilitates ease of removal without significant associated pain. Administration of lidocaine and non-steroidal anti-inflammatory drugs (NSAID’S) as a routine procedure for the relief of dental pain and restricted to some side effects. Amitriptyline is a tricyclic antidepressant that provides local anesthetic effects by blocking the sodium channels. It inhibits reuptake of nor epinephrine and serotonin almost equally. The aim of this work is to design Amitryptyline muco-adhesive buccal films, using muco-adhesive polymers, widely employed for the successful treatment of depression, psychotic conditions, facial pain and dental pain management. Amitriptyline buccal films were prepared using HPMC in different proportions in combination with glycerin as plasticizer, acetone as solvent. The thickness values of the films ranged between 0.1753 ± 0.0055mg and 0.2125 ± 0.0053mg. The weight of films ranged between 19.4 ±1.3115mg and 20.5±1.36mg.The invitro release of Amitriptyline from the F2 to F4 was in the range of 70 to 96 % in 80 min in phosphate buffer solution pH – 6.6. Films did not show any cracks even after folding for more than 300 times. The surface pH of all Amitriptyline patches was within ± 0.3 units of the neutral pH and hence no mucosal irritation is expected. The films exhibited satisfactory characteristics regarding integrity, flexibility, dispersion of drug and other quality control parameters. Ultimately patient compliance is achieved.

Keywords: Amitryptyline Hcl, Oral Drug Delivery, Buccal Films, Bioadhesion, solvent casting method.