Formulation Development and Evaluation of Taste Masked Chewable Tablet of Sildenafil Citrate

Sasikumar, R (2017) Formulation Development and Evaluation of Taste Masked Chewable Tablet of Sildenafil Citrate. Masters thesis, Arulmigu Kalasalingam College of Pharmacy, Krishnankoil.

261510402Sasikumar R.pdf

Download (5MB) | Preview


AIM AND OBJECTIVE: The main aim and objective of this study is to formulate and evaluate chewable tablet of taste masking sildenafil citrate. REASON FOR SELECTION OF CHEWABLE TABLETS OF TASTE MASKING SILDENAFIL CITRATE Clinically selective inhibitor of phosphodiesterase type 5 enzymes (PDE5) is extensively used for the treatment of erectile dysfunction. Conventional sildenafil citrate tablet available in the marked are not suitable where onset of action is slow. Thus chewable tablet achieve high bioavailability and rapid onset of action. Particularly one that disintegrates and dissolves or disperses in saliva and administered without need of water. It has unacceptable taste and present study to formulate the chewable tablet with taste masked. My attempt was made in the present work to formulate and evaluate chewable tablet of sildenafil citrate. "Generally, in man, oral administration of the phospho diesterase inhibitors is the preferred route, being the most convenient and avoiding the disadvantages associated with intra cutaneous administration. Phospho diesterase inhibitors include drugs such as Sildenafil Citrate and they are available in the market in form of a filmcoated tablet, wherein, film-coating has to dissolve and tablet has to disintegrate into granules and further the drug has to release for dissolution in acidic media of stomach. Normal mouth dispersible tablets release the drug for absorption in oral cavity. Further Sildenafil is very bitter to taste PDE inhibitors. Hence formulation development is very critical. Effectiveness of any phospho diesterase inhibitor formulation will depend upon initial complexation to the extent necessary to bypass complex after pH adjustment in digestive tract. Dispersible tablets are the formulations that elude the process of disintegration that occurs with conventional formulation, dispersible tablets are formulated to make the drug product bio-available at a faster rate for immediate action. In the present study of sildenafil citrate was designed, for the following reasons.  Sildenafil citrate pure drugs are bitter taste. Ph-modification method. Higher dosage forms are administered into the chewable tablet form. Prevent from into the first pass metabolism. High solubility and high permeability.  Sildenafil citrate is used in the treatment of erectile dysfunction and also used into the pulmonary hypertension. Sildenafil citrate has a vasodilator properties resulting in mild and transient decrease in the blood pressure. Quick on set of action. MORINGA OLEIFERA: Moringa oleifera is a small genus of quick growing tree distributed in India. The stem of the tree exudes a gum which is initially white in colour but changes to reddish brown or brownish black on exposure to sunlight. It is sparingly soluble in water but swells in contact with water giving a highly viscous solution. Moringa oleifera gum Binder and release retardant in tablet. Binders are agents used to cohesive quality to the material during the production of the tablet. They import cohesiveness of the tablet formulation. Which ensures that the tablet remain intact after compression as well as improving the free flowing quality. Binders have been used as the solution in the formulation and the method of preparation. The choice of a particular binding agent depends on the binding force required to form the granules and compatability with the other ingredients particularly the active drug. It is polyuronide consisting of arabinose, galactose and glucoronic acid in the proportion of 10:7:2, rhamnose is present in traces. It was observed that drug release increased with increasing proportions of the excipient and decreased proportion of the gum. Gum was also studied for its disintegrating property. Different batches of tablets were formulated varying them by quantity of the gum. It was observed that wetting time decreased with the increase in concentration of gum in formulation. SUMMARY AND CONCLUSION: The chewable tablets of taste masked sildenafil citrate were successfully prepared by direct compression method and wet granulation method. 12 batches using various additives were prepared and evaluated with an aim of presenting sildenafil citrate taste masked by the chewable tablet. Drug excipient compatibility study was performed by FTIR. The unpleasant taste of the sildenafil citrate was masked by intra-granular addition of dried calcium carbonate, calcium carbonate from oyster shell and the extra-granular addition of sweeteners and flavoring agents. Taste masking study was done by using alkalizing agent in different ratio. Sildenafil citrate taste masking was increased when dried calcium carbonate quantity was increased because of reduction of the solubility of sildenafil citrate. Oyster shell calcium carbonate when added to the drug did not masked the taste due to the gritty nature of it. F5 batch showed less bitterness, low disintegration time and fast dissolution time and hence was taken further comparing with the innovator drug. In the present study disintegrating properties of Moringa Oleifera gum powder had been studied in comparison with other commercially available super disintegrants. The isolated natural disintegrant exhibits faster drug dissolution and disintegration. The isolated gum powder can be effectively used as disintegrant for sildenafil citrate with the added advantage of the folkloric aphrodisiac activity of it. The physicochemical evaluation results for the powdered blend of all trials pass the official limits in the angle of repose, compressibility index, Bulk density, Tapped density, Hausner’s ratio. Hence it may be summarized that the tablets prepared by direct compression method might be a perfect and effective formulation to prevent the side effects in treating erectile dysfunction”. taste buds without detection with the ability to subsequently release the drug from the

Item Type: Thesis (Masters)
Uncontrolled Keywords: Taste Masked Chewable Tablet ; Sildenafil Citrate
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 19 Dec 2017 09:47
Last Modified: 19 Dec 2017 09:47

Actions (login required)

View Item View Item