Preparation and optimization of fast disintegrating tablets of isosorbide dinitrate using lyophilization method for oral drug delivery

Background: Orally disintegrating tablets rapidly disintegrate in saliva and then swallowed without the need for water. Materials & methods: The orally disintegrating tablets were prepared by freeze-drying of an aqueous dispersion of isosorbide dinitrate containing a matrix former (gelatin), a cryoprotectant (mannitol), a plasticizer (glycerin) and a dissolution enhancer (Tween/polyethylene glycol). Results: Results demonstrated that the selected formulation, Ft9, disintegrated within 1 min and showed faster dissolution rate compared with the commercial tablet. Conclusion: Having a fast disintegration time, the developed lyophilized tablet does not need to be swallowed as a whole. So, it is a convenient solid oral dosage form for the patients who have difficulty with swallowing such as the pediatric and elderly ones.

A REVIEW ON PHARMACEUTICAL MINI TABLETS: NEW MODALITY TO ORAL DRUG DELIVERY

The purpose of any selected drug delivery system (DDS) is to deliver drug to target site and to get the desired drug concentration for effective therapy. The main purpose of designing controlled or sustained DDS is to decrease the frequency of dosing and maximizing its efficiency by confining the area of action of the drug to a selected region. It is well-identified that solid oral dosage form, particularly tablets, is the most satisfactory form of delivering medication. In addition, some new variations are emerging such as mini tabs which offer more formulation flexibility. Oral controlled release DDS are classified into two categories like single unit dosage forms which include tablets, capsules, and multiple-unit dosage forms include pellets, granules, or mini tablets. Mini tablets are a new development in solid dosage forms and more beneficial and great substitute for granules and pellets. Mini tablets defined as tablets which are having diameter <3 mm and promising patient friendly drug delivery system and more acceptable in small children’s and old age people as they are easy to swallow and offer therapeutic benefits such as manufactured relatively easy, dose and formulation flexibility, combination release pattern, coating, and less solvent requirement. Dose dumping and local irritation can be avoided using mini tablets. This review highlights the various advantages of mini tablets, manufacturing processes, formulation possibilities, and their challenges.

Formulation and evaluation of fast disintegrating tablets of metoprolol succinate using various superdisintegrants

The aim of present work is to develop a fast disintegrating solid oral dosage form of Metoprolol succinate. The concept of fast dissolving drug delivery system emerged from the desire to provide patient with more conventional means of taking their medication. Problems associated with conventional tablets can be resolved by means of fast dissolving tablets when put on tongue these tablets disintegrate and dissolve rapidly in saliva without need of drinking water. The faster the drug disintegrates in to solution, the quicker the absorption and onset of clinical effect. Preformulation results reveal that the flow properties of the active pharmaceutical ingredient were found to be excellent as per IP limits. To perform drug-polymer compatibility FT-IR studies were carried out and observed that there was no interaction between the APl and excipients. Eight formulations were prepared with varying super disintegrating agent ratios and were found that as the level of super disintegrating agent decreased the drug release rates were found to be increased. Amongst all the formulations, formulation containing CCS (F4) as super disintegrant is fulfilling all the parameters satisfactorily. It has shown excellent in-vitro disintegration, in-vitro dissolution compared to other formulations. The prepared tablets disintegrate within few minutes without need of water; thereby enhance the absorption leading to its increased bioavailability. It was concluded that Fast Disintegrating tablets of Metoprolol can be prepared successfully as it satisfies all the criteria as a dispersible tablet and would be alternative to the currently available conventional tablets. Prepared formulations were stable during 90 days storage period at controlled 40°C and 75%RH.

An Overview of Fast Dissolving Oral Film

Taste-masking techniques are applied to mask or overcome the bitter or unpleasant taste of active pharmaceutical ingredients/drugs to achieve patient acceptability and compliance. Oral administration of bitter or unpleasant tasting drugs is often the biggest barrier for patient groups, such as pediatrics and geriatrics [1, 2]. Unless the active ingredient is tasteless or does not have any unpleasant taste, taste-masking plays a key role in the success of a final solid oral dosage form. The efficiency of taste-masking is often a key determinant for the success of specialized dosage forms like orally disintegrating tablets and films, and chewable tablets [2]. The mechanisms of taste-masking techniques often rely on two major approaches: the first is to add sweeteners, flavors, and effervescent agents to mask the unpleasant taste, and the second is to avoid the contact of bitter/unpleasant drugs with taste buds. In the past few years, significant progress has been made in the area of taste-masking by applying novel strategies and techniques, such as hot-melt extrusion and microencapsulation.[1,3] The following presents an overview and current status of the industrial approaches and platforms used for taste-masking in oral dosage forms. [1, 2, 4] Many pharmaceutical companies are switching their products from tablets to fast dissolving oral thin films (OTFs).[6,7] Films have all the advantages of tablets (precise dosage, easy administration) and those of liquid dosage forms (easy swallowing, rapid bioavailability). Statistics have shown that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosages forms. Pediatric, geriatric, bedridden, emetic patients and those with Central Nervous System disorders, have difficulty in swallowing or chewing solid dosage forms.[7,8] Many of these patients are non-compliant in administering solid dosage forms due to fear of choking.[9] OTFs when placed on the tip or the floor of the tongue are instantly wet by saliva. This technology provides a good platform for patent non- infringing product development and for increasing the patent life-cycle of the existing products. [10, 11]

SPLIT-HALF TABLETS: A COMPLETE REVIEW FOR ANALYTICAL TESTING

A solid oral dosage form (as a tablet) which is an immediate or extended-release dosage form which necessitates the scoring bisect of the tablet. This review discusses the quality attributes and interpretations for the split studies of the various tablet formulations using the analytical techniques. Each method of analysis for the evaluation of split-half tablets in terms of its critical quality attributes discusses in detail explanation of analytical methodology and challenges in formulation development. The results for quantitative analytical evaluation in terms of finished product/stability testing and release of the split-half drug product against the acceptance criterion and also discusses the flowchart guidance for the investigation of out of specification results. The present article provides an insight into the complete analytical evaluation of split-half drug product testing according to the requirements of tablet scoring as per US food and drug administration.