Abstract
Objective: The present investigation was aimed at preparation and evaluation of mouth dissolving films (MDFs) of Ramipril to enhance patient convenience, compliance and to improve bioavailability.
 Methods: MDFs with 0.5% w/w Ramipril were prepared by a solvent casting method using a wet film applicator. The effects of film formers, wetting/solubilizing, saliva stimulating agents and film modifiers on the physicomechanical and in vitro Ramipril release from MDFs were evaluated.
 Results: The MDFs prepared were transparent, smooth and showed no re-crystallization upon storage. MDFs casted with hydroxypropyl methylcellulose (HPMC) E3 as film former and polyethylene glycol (PEG-400) as plasticizer showed superior Ramipril release rates and good physicomechanical properties when compared to MDFs with E5 and E15 as film formers. HPMC E3 MDFs with polyvinyl pyrrolidone K30 (PVP K30) and sodium lauryl sulphate (SLS) gave superior drug release properties than MDFs without PVP K30 and SLS. The HPMC E3 MDFs with citric acid (CA) as saliva stimulating and xylitol as soothing agent gave significantly superior in vitro drug release than the MDFs without CA and xylitol. Release kinetics data reveals diffusion as a drug release mechanism.
 Conclusion: From the obtained results, it can be concluded that the administration of Ramipril as MDF may provide a quick onset of action with enhanced oral bioavailability and therapeutic efficacy.
Highlights
Hypertension is a chronic medical condition involving the elevated blood pressure levels
It can be concluded that ramipril can be successfully formulated into mouth dissolving films (MDFs)
The film properties and drug release rates can be affected by the formulation variables such as polymer viscosities, wetting/solubilizing agents and saliva stimulating agents
Summary
Hypertension is a chronic medical condition involving the elevated blood pressure levels. Most of the anti-hypertensives are available in the oral or parenteral dosage forms, which have certain limitations such as swallowing and chocking difficulties, delayed onset of action, first pass metabolism, the requirement of skilled personnel and pain during delivery. These limitations and a need for the quicker onset of action with better patient acceptability has paved the way for the development of mouth dissolving films (MDFs) as an alternative to other dosage forms [2]. The drug is directly absorbed into the systemic circulation which by-passes the first pass metabolism, improving the bioavailability of the drug [5]
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