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Formulation and Evaluation of fast dissolving Tablet: A Review

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Formulation and Evaluation of fast dissolving Tablet: A Review
  Formulation and Evaluation of fast dissolving Tablet: A Review Pavitra Solanki* 1 , Pradhumna kumar patel 2 , S.K. Prajapati 2 , Shailendra kannauji 2 , Bharat Garg 3  1-   Assistant Professor, Sanjay College of Pharmacy, Mathura, Uttar Pradesh, India 2-   Institute of pharmacy,Bundelkhand University, Jhansi(U.P) 3-   Assistant Professor, ITS Paramedical (Pharmacy) College, Ghaziabad, U.P. Abstract Over the past three decades, Orally Disintegrating Tablet (ODT) has gained much attention as a  preferred alternative to conventional oral dosage form such as tablet and capsules. These dosage forms are placed in the mouth, allowed to disperse in the saliva, to produce a suspension which can be easily swallowed by the patient. In addition, patients suffering from dysphagia, motion sickness, repeated emesis and mental disorders prefer these medications because they cannot swallow large quantity of water. Further, drugs exhibiting satisfactory absorption from the oral mucosa or intended for immediate pharmacological action can be advantageously formulated in these dosage forms. Fast dissolving tablets are solid dosage forms containing drugs that disintegrate in the oral cavity within less than one minute leaving an easy-to-swallow residue. These dosage forms are placed in the mouth, allowed to disperse or dissolve in the saliva. The release the drug as soon as they come in contact with the saliva, thus obviating the need for water during administration. The aim of this article is to review the progress of the evolving technologies and super disintegrating agents in the formulation, manufacturing and evaluation of these tablets.Various modifications in the conventional evaluation and use of specialized instruments are found to be essential in the testing of these dosage forms. In the present review the formulation techniques and different technologies are discussed. Keywords: Fast Dissolving Tablets, orally disintegration tablet, Freez drying, moulding. Corresponding Author: Pavitra Solanki, Dept. of Pharmaceutics, Sanjay College of Pharmacy, Mathura, U.P. India. Address:   High Tech Building, Near SBI, Bichpuri, Agra. Phone: +918909357007, +919548520319 Email:   Introduction In recent decades, a variety of pharmaceutical research has been conducted to develop new dosage forms. Considering quality of life, most of these efforts have been focused on ease of medication. Among the various dosage forms developed to improve the ease of administration, the fast dissolving tablet (FDT) is the most widely preferred commercial products 1 . Rapid- breakdown or fast disintegrating tablet of the type of those intended to undergo disaggregation in the mouth in contact with the saliva in less than 60 seconds, preferably in less than 40 seconds, forming a suspension which is easy to swallow. It is better known by the phrase "orodispersible tablets" 2,3 . The concept of Fast Dissolving Drug Delivery System emerged from the desire to provide  patient with more conventional means of taking their medication. It is difficult for many patients to swallow tablets and hard gelatin capsules. Hence they do not comply with prescription, which results in high incidence of non-compliance and ineffective therapy. In some cases such as motion sickness, sudden episodes of allergic attacks or coughing and unavailability of water, swallowing conventional tablets may be difficult. Particularly the difficulty is experienced by  pediatric and geriatric patients. Such problems can be resolved by means of Fast Dissolving Tablet. When put on tongue, this tablet disintegrates instantaneously, releasing the drug, which dissolves or disperses in the saliva. Some drugs are absorbed from the mouth, pharynx and esophagus as the saliva passes down into the stomach. In such cases, bioavailability of drug is significantly greater than those observed from conventional tablet dosage form. 4  Orally disintegrating dosage forms can serve as an effective alternative mode of drug delivery in such situations. When put in the mouth, these dosage forms disintegrate instantly to release the drug, which dissolves or disperses in the saliva.Thereafter, the drug may get absorbed from the  pharynx and oesophagus or from other sections of g.i.t as the saliva travels down. In such cases,  bioavailability is significantly greater than that observed from conventional tablet dosage form [5-6]  The oral cavity is an attractive site for the administration of drugs because of ease of administration. Various dosage forms like Tablets, Capsules, Liquid preparations are administered by oral route 7 . Orally disintegrating tablets provide an advantage particularly for pediatric and geriatric  populations who have difficulty in swallowing conventional tablets and capsules. Additionally,   pediatric patients may suffer from ingestion problems as a result of underdeveloped muscular and nervous control. Moreover, patients traveling with little or no access to water, limit utility of orally administered conventional tablets or capsules. Fast dissolving of tablet results in quick dissolution and rapid absorption which provide rapid onset of action. Moreover, drug candidates that undergo pre-gastric absorption when formulated as FDTs may show increased oral  bioavailability. It provides good stability, accurate dosing, easy manufacturing 8,9  Ideal Properties 10,11 : An ideal FDT should: 1.   Require no water for oral administration. 2.   Have a pleasing mouth feel. 3.   Have an acceptable taste masking property. 4.   Be harder and less friable. 5.   Leave minimal or no residue in mouth after administration. 6.   Exhibit low sensitivity to environmental conditions (temperature and humidity). 7.   Allow the manufacture of tablet using conventional processing and packaging equipments. Advantages 10,11 : 1.   Administration to the patients who cannot swallow, such as the elderly, bedridden  patients, patients affected by renal failure & patients who refuse to swallow such as  pediatric, geriatric & psychiatric patients. 2.   Rapid drug therapy intervention. 3.   Achieve increased bioavailability/rapid absorption through pre-gastric absorption of drugs from mouth, pharynx & esophagus as saliva passes down. 4.   Convenient for administration and patient compliant for disabled, bedridden patients and for travelers and busy people, who do not always have access to water. 5.   Good mouth feel property helps to change the perception of medication as bitter pill  particularly in pediatric patients.  6.   The risk of chocking or suffocation during oral administration of conventional formulations due to physical obstruction is avoided, thus providing improved safety.  New business opportunity like product differentiation. Salient Features 10 :    Ease of administration to patients who refuse to swallow a tablet, such as pediatric and geriatric patients and, psychiatric patients.    Convenience of administration and accurate dosing as compared to liquids.    Rapid dissolution of drug and absorption which may produce rapid, onset of action. Some drugs are absorbed from the pharynx and oesophagus as the saliva passes down into the stomach, in such cases bioavailability of drugs is increased.    Ability to provide advantages of liquid medication in the form of solid preparation.    Pre-gastric absorption can result in improved bioavailability and as a result of reduced dosage, improved clinical performance through a reduction of unwanted effects. Technology for   Fast   dissolving Tablets : Conventional Techniques 7 : Disintegrates addition: Disintegrate addition technique is one popular techniques for formulating Fast-dissolving tablets because of its easy implementation and cost-effectiveness. The basic principle involved in formulating Fast-dissolving tablets by disintegrates addition technique is addition of superdisintegrants in optimum concentration so as to achieve mouth dissolving along with the good mouth feel. 1. Molding: In this method, molded tablets are prepared by using water-soluble ingredients so that the tablets dissolve completely and rapidly. The powder blend is moistened with a hydro-alcoholic solvent and is molded into tablets under pressure lower than that used in conventional tablet compression. The solvent is then removed by air-drying. Molded tablets are very less compact than compressed tablets. These possess porous structure that enhances dissolution. 2. Freeze drying:  A process in which water is sublimated from the product after freezing. Lyophilization is a pharmaceutical technology which allows drying of heat sensitive drugs and biological at low temperature under conditions that allow removal of water by sublimation. Lyophilization results in preparations, which are highly porous, with a very high specific surface area, which dissolve rapidly and show improved absorption and bioavailability. 3. Sublimation: The slow dissolution of the compressed tablet containing even highly water-soluble ingredients is due to the low porosity of the tablets. Inert solid ingredients that volatilize. Micromeritic properties 1. Determination of bulk density and tapped density:- A weighed amount of blend was poured into a graduated cylinder and the volume (V 0 ) was noted. Then the graduated cylinder was fixed on the density apparatus and the timer knob is set for 100 tapping and after that volume (V f  ) was measured and continued operation till the two consecutive readings were equal. The bulk density and tapped density were calculated by using the following formulae.   Bulk density = W/ V 0  Tapped density = W/ V f   Where W = weight of the powder. V 0 = Initial volume of the powder. V f  = Final volume of the powder. 2. Carr’s Compressibility Index :- Compressibility Index is an important measure to calculate the flowability of powders. This can be obtained from bulk and tapped densities. It is represented as percentage. In theory, the less compressible a material the more flowable it is. Tapped density –   Bulk density Compressibility [%] = —————————————  x 100 Tapped density
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