Objective: To evaluate starch xanthate as a super disintegrant in the formulation of fast dissolving tablets of poorly soluble drugs employing 23 factorial design.Methods: Starch xanthate was synthesized by gelatinization process. The synthesized starch xanthate was subjected to physical and micromeritic evaluation. To establish as starch xanthate as a super disintegrant, fast dissolving tablet of ibuprofen was prepared employing starch xanthate in different proportions in each case by direct compression method employing 23 factorial design. All fast dissolving tablets prepared were evaluated for drug content, hardness, friability, disintegration time and other dissolution characteristics like percent dissolved in 5 min (PD5), Dissolution efficiency in 5 Min (DE5%) and first order rate constant(K1).Results: The starch xanthate prepared was found to be fine, free flowing slightly crystalline powder. Starch xanthate exhibited good swelling in water. Fourier transform infrared spectra (FTIR) and Differential scanning calorimetry (DSC) study indicated the absence of interaction between Ibuprofen and starch xanthate. All the fast dissolving tablets formulated employing starch xanthate were of good quality with regard to drug content(100±5%), hardness (3.6–4 kg/sq. cm), and friability (0.12-0.15%). The disintegration time of all the formulated tablets was found to be in the range of 13±0. 02 to 108±0.02s. The optimised formulation FL7 has the least disintegration time i.e., 13±0. 02s. The In vitro wetting time of the formulated tablets was found to be in the range of 90±0.15 to 369±0.17s. The In–Vitro wetting time was less (i.e., 90s) in optimized formulation FL7. The water absorption ratio of the formulated tablets was found to be in the range of 94±0.16 to 192±0.15%. The cumulative drug dissolved in the optimized formulation FL7 was found to be 99.63±0.24% in 5 min.Conclusion: Starch xanthate was found to be a super disintegrant which enhanced the dissolution efficiency when combined with sodium starch glycolate, croscarmellose sodium, with the ibuprofen and hence it could be used in the formulation of fast dissolving tablets to provide immediate release of the contained drug within 5 min.
Objective:The objective of the present research was to prepare starch phthalate (a novel super disintegrant) and to optimize and formulate ibuprofen fast dissolving tablets employing 2 3 factorial design using starch phthalate as super disintegrant. Methods:Drug excipient compatibility studies like Fourier-transform infrared spectroscopy (FTIR) and thin-layer chromatography (TLC) studies were carried out to check the drug interaction between ibuprofen and starch phthalate. Direct compression method was used for tablet preparation. Prepared tablets were then evaluated for hardness, friability, drug content, disintegration time, water absorption and wetting time, in vitro dissolution studies. Response surface plots and contour plots were also plotted to know the main effects and interaction effects of independent variables (starch phthalate (A), croscarmellose sodium (B) and crospovidone (C)) on dependent variables (disintegration time and drug dissolution efficiency in 1 minute) and stability studies were also done. Results:Tablets of all formulations were of good quality concerning drug content (100±5%), hardness (3-6 kg/cm2), and friability (less than 0.16%). In all formulations, formulation F5 found to be optimized formulation with least disintegration time 20±0.28 seconds, less wetting time 09±0.12 seconds and enhanced dissolution rate in one minute, i.e., 91.95±0.22 as compared to other formulation. Conclusion:From the research, it was concluded that on combination with crospovidone, starch phthalate enhanced the dissolution efficiency of the drug. Hence, starch phthalate can be used as a novel disintegrant in the manufacturing of fast dissolving tablets.The starch phthalate prepared was evaluated for the following SolubilityThe solubility of starch phthalate was tested in water, an aqueous buffer of pH 1.2, 4.5, 7.4 and organic solvents like petroleum ether, alcohol, acetone, dichloromethane, chloroform.pH By pH meter, pH of 1% w/v slurry was checked.
Transdermal drug delivery systems (TDDS), which are self-administrable and non-invasive, can improve bioavailability and patient compliance by bypassing first-pass metabolism. Vesicular-based TDDS have attracted a lot of attention in recent years because they're designed for controlled, efficient, and targeted drug delivery. One of these delivery technologies, transferosomal-based formulations, has grown in popularity due to its ability to achieve all of the desired criteria and quality qualities. Transferosomes combine the characteristics of liposomes and niosomes because they contain both liposomes (phospholipids and cholesterols) and niosomes as components (nonionic surfactants; edge activators). as a result, they are referred to as the first generation of elastic liposomes. However transdermal drug delivery is difficult due to the presence of the skin's protective barrier, transferosomal drug delivery overcomes all obstacles due to its unique characteristics, such as its ultradeformable vesicular nature. The benefits, limitations, modes of penetration, formulations, production and assessment methodologies, and pharmaceutical uses of transferosomal drug delivery systems are discussed in this paper. Conclusion: Transferosomes have several importance over other vesicular systems, including greater deformability, greater penetration power across skin, the ability to deliver systemic drugs, and higher stability.
The oral route is most familiar route as it has low cost of therapy and helps in the ease of administration of therapeutic agents which lead to high levels of patient compliance. The most known oral solid dosage forms are tablets and capsules. Many patients’ particularly pediatric and geriatric patients find it difficult to swallow tablets and hard gelatin capsules and do not take their medicines as prescribed. Difficulty in swallowing or dysphagia is identified to afflict nearly 35% of the general population. To reduce these difficulties, the growth of several fast dissolving drug delivery systems has been produced. Oral dissolving film is relatively a new dosage form in which thin film is prepared using hydrophilic polymers, which rapidly dissolves on tongue or buccal cavity. The film overcomes the danger/fear of choking. An ideal film should have the characteristics like pleasant taste, high stability, ease of handling and administration, no water necessary for administration. The present review focuses on hydrophilic polymers, plasticizers, sweeteners, flavors and colors etc which are used in the formulation of oral dissolving films including the manufacturing aspects of oral dissolving film like solvent casting method, rolling method, extrusion method and solid dispersion method and evaluation parameters like disintegration, dissolution, tensile strength, thickness, folding endurance, elastic modulus for oral dissolving films.
In the pharmaceutical R&D the evaluation procedures play a key role in developing a potent graded product focusing on the various technical advancements it’s easy to overcome hazards.Emphasis is placed on the product’s development to reach specifications of USFDA ,US Pharmacopeia, National Formulary for achieving standards that provide insight on evaluation techniques of drug formulation.Adoption of guidance’s and guidelines cited will strive for achieving good laboratory practice(GLP) good clinical practice(GCP) and good manufacturing practice(cGMP).Embracing statistical approach provides accuracy and reliability of results.
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