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.
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.
The current scenario deals with the study of fast dissolving tablets for the patients suffering from swallowing, sickness ,etc. The present investigation involves in the evaluation of starch tartrate as a superdintegrant in the formulation of fast dissolving tablets of poorly soluble drugs employing 23factorial design. Starch tartrate was synthesized by esterification process. The synthesized starch tartrate was subjected to physical and micromeritic evaluation. All fast dissolving tablets 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). The starch tartrate prepared was found to be fine, free flowing slightly crystalline powder. Starch tartrate 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 tartrate. All the fast dissolving tablets formulated employing starch tartrate were of good quality with regard to drug content (200±5%), hardness (3.6–3.9 kg/sq. cm), and friability (0.12-0.15%). The optimised formulation F2 has the least disintegration time i.e., 9±0. 03s. The in–vitro wetting time was less (i.e., 60s) in optimized formulation F2. The water absorption ratio of the formulated tablets was found to be in the range of 27.53±0.12 to 69.75±0.18%. The cumulative drug dissolved in the optimized formulation F2 was found to be 100.17±0.56% in 5 min. Starch tartrate was found to be a superdisintegrant which enhanced the dissolution efficiency with the ibuprofen and hence it could be used in the formulation of fast dissolving tablets to bring immediate release of the contained drug within 5 minutes. Keywords: Fast dissolving, Superdisintegrant, Starch tartrate, Dissolution efficiency.
The present study involves in the evaluation of starch xanthate as a superdintegrant in the formulation of fast dissolving tablets of poorly soluble drugs employing 23factorial design. By using gelatinization process starch xanthate was synthesized. Then the synthesized starch xanthate was evaluated under physical and micromeritic methods. To develop starch xanthate as a superdisintegrant, fast dissolving tablet of aceclofenac was prepared by direct compression method employing starch xanthate in different proportions in each case employing 23 factorial design. All the prepared fast dissolving tablets were evaluated for drug content, hardness, friability, disintegration time and other dissolution characteristics like PD10, DE5 and K1. The prepared starch xanthate was found to be fine, free flowing slightly crystalline powder. Starch xanthate shown good swelling in water. The swelling index was 50% and all micrometric properties shown good flow and compressibility needed for solid dosage from manufacturing. All the formulated fast dissolving tablets employing starch xanthate were of good quality with regard to drug content, hardness and friability and fulfilled the official (IP/USP) requirements of compressed tablets with regard to the above mentioned physical properties. Starch xanthate was found to be a superdisintegrant which enhanced the dissolution efficiency when combined with croscarmellose sodium, with the aceclofenac and hence it could be utilized in the formulation of fast dissolving tablets to provide immediate release of the contained drug within 10 minutes. Keywords: Fast Dissolving, Superdisintegrant, Starch xanthate, Dissolution efficiency
Objective: To enhance the solubility of poorly soluble drugs by using 23 factorial design in the formulation of fast dissolving tablets by employing starch oxalate as a superdisintegrant. Methods: Starch oxalate was synthesized by gelatinization process. The physical and micromeritic properties were performed to evaluate the synthesized starch oxalate. By using 23 factorial design, atenolol fast dissolving tablet was prepared by employing starch oxalate as a superdisintegrant in different proportions in each case by direct compression method. In the evaluation of fast dissolving tablets the drug content, hardness, friability, disintegration time and other dissolution characteristics were utilized. Results: The starch oxalate prepared was found to be fine, free-flowing completely amorphous powder. The compatibility between atenolol and starch oxalate were studied and showed no interaction. The drug content, hardness, and friability have been effective with regard to all the formulated fast dissolving tablets employing starch oxalate. The optimised formulation F8 has the least disintegration time i.e., 24±0.06s. The In–vitro wetting time was less (i.e., 28s) in optimized formulation F8. The water absorption ratio of the formulated tablets was found to be more in F8 formulation 94.42±0.18%. The cumulative drug dissolved in the optimized formulation F8 was found to be 98.70±0.24% in 5 min. Conclusion: The dissolution efficiency of atenolol was enhanced when starch oxalate was found to be a superdisintegrant when combined with sodium starch glycolate, crospovidone and, hence to provide immediate release of the formulated fast dissolving tablets contained drug it could be used.
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