DESIGN AND EVALUATION OF ORO – FLASH RELEASE FILMS OF AMLODIPINE BESYLATE
HTML Full TextDESIGN AND EVALUATION OF ORO – FLASH RELEASE FILMS OF AMLODIPINE BESYLATE
M. Sreekanth*, Md. Gulshan, Eswar M. Gupta and N. Rama Rao
Department of Pharmaceutics including Industrial Pharmacy, Chalapathi Institute of Pharmaceutical Sciences, Lam, Guntur, Andhra Pradesh, India
ABSTRACT: This work aimed to formulate amlodipine besylate Oro flash release films by solvent casting method. Various film forming polymers like Hydroxy propyl methyl cellulose (HPMC) E5, HPMC E15, sodium carboxymethyl cellulose, sodium alginate, xanthan gum were used and out of which HPMCE5 was found to be satisfactory. Propylene glycol was used as plasticizer at a range of 13-32%w/w of the film and 31%w/w was found to be the best concentration based on the flexibility and the strength of the film. Optimized formulation contains HPMC E5 as a film forming agent, propylene glycol as a plasticizer, tween 80 as a surfactant, peppermint oil as flavoring agent and aspartame as sweetening agent. Films were prepared by solvent casting method and found to satisfy the mouth dissolving time and other film parameters. 1.5 x 1.5 cm of film is required to be placed on to patient tongue which gets wet by saliva, rapidly hydrates, adheres to tongue and rapidly disintegrates and dissolves to release the drug for the oro – mucosal absorption or allow for gastrointestinal absorption when swallowed. The formulated films exhibited acceptable film endurance. Time required for the film to dissolve and release is 45 seconds and 5 minutes respectively. It can be concluded from the study that the oro flash release film can be a potential novel drug dosage form for poorly water – soluble drugs.
Keywords: |
Fast dissolving drug delivery, Fast dissolving oral films (FDOFs), Oral thin film (OTF), Oro – Flash release films, Amlodipine besylate, HPMC E5, Solvent casting, Oro - mucosal absorption, Poorly water soluble drugs
INTRODUCTION:A vast variety of pharmaceutical research is directed at developing new dosage forms.
Most of these efforts have focused on either formulating novel drug delivery systems or increasing the patient compliance.
Among the dosage forms developed for ease of medication, the orally disintegrating systems have been the favorite of product development scientists 1.
Recent developments in this technology have presented viable fast – dissolving oral delivery system as alternatives from oral route for pediatrics, geriatric, bedridden, nauseous or non – compliant patients. Fast – dissolving oral delivery systems are solid dosage forms, which disintegrate or dissolve within 1 min when placed in the mouth without drinking or chewing 2. More recently, fast dissolving films are gaining interest as an alternative to fast – dissolving tablets to definitely eliminate patient’s fear of chocking and overcome patient impediments. Fast – dissolving films are generally constituted of plasticized hydrocolloids or blends made of thereof that can be laminated by solvent casting or hot melt extrusion.
Intraoral fast dissolving drug delivery system is placed on the top or the floor of the tongue. It is retained at the site of application and rapidly releases the active agent for local and/systemic absorption. Patients suffering from dysphasia, repeated emesis, motion sickness and mental disorders prefer this dosage form as they are unable to swallow large quantity of water. The oral or buccal mucosa being highly vascularized, drugs can be absorbed directly and can enter the systemic circulation without undergoing first – pass hepatic metabolism. This advantage can be exploited in preparing products with improved oral bioavailability of molecules that undergo first pass effect 3. Different marketed film products were listed in the Table 1.
TABLE 1: LIST OF MARKETED FILM PRODUCTS 4, 5
Distributor | Brand | API | Strength |
Del | Orazel | Menthol /pectin | 2mg/30mg |
Inno Zen | Suppress | Menthol | 2.5mg |
Novartis | Gas – X | Simethicone | 62.5mg |
Novartis | Theraflu | Phenylepherine HCl/Dextromethorphan HBr | 10mg/20mg |
Novartis | Theraflu | Phenylepherine HCl/Dextromethorphan HCl | 10mg/25mg |
Novartis | Theraflu | Dextromethorphan HBr | 15mg |
Novartis | Theraflu | Diphenhydarmine HCl | 25mg |
Novartis | Triamnic | Diphenhydarmine HCl | 12.5mg |
Novartis | Triamnic | Phenylepherine HCl | 2.5mg |
Novartis | Triamnic | Phenylepherine HCl/lDiphenhydarmine HCl | 5mg/12.5mg |
Novartis | Triamnic | Dextromethorphan HBr | 7.5mg |
Novartis | Benadryl | DiphenylhydramineHCl | 12.5mg |
Pfizer | Benadryl | DiphenylhydramineHCl | 25mg |
Pfizer | Suldafed | phenylepherineHCl | 10mg |
Prestige%3 |
Article Information
44
2428-2435
681KB
1869
English
IJPSR
M. Sreekanth*, Md. Gulshan, Eswar M. Gupta and N. Rama Rao
Department of Pharmaceutics including Industrial Pharmacy, Chalapathi Institute of Pharmaceutical Sciences, Lam, Guntur, Andhra Pradesh, India
sreekanthmachavarapu@gmail.com
06 October, 2013
19 February, 2014
03 May, 2014
http://dx.doi.org/10.13040/IJPSR.0975-8232.5(6).2428-35
01, June 2014