Formulation and evaluation of taste masked oral disintegrating tablets of lornoxicam

Orally disintegrating tablets (ODT) disintegrate quickly with saliva when administered into the oral cavity and taken without water or chewed. ODT are easy to take for children and the elderly, who may experience difficultly in taking ordinary oral preparations such as tablets, capsules, and powders. The ODT threes substantial benefits for the patient (or elder) who cannot swallow (Dysphagia), or who is not permitted water intake due to disease. The reason of the current research was to prepare taste masking oral disintegrating tablets of poorly soluble lornoxicam (LXM) by direct compression technique using Kyron T-114 (cation exchange resin) as a taste masking agent. With in various ratios the Drug-resin of 1:4 was established to present best taste masking. The superdisintegrants used in formulation are croscarmellose sodium and cross povidone. Among these croscarmellose sodium demonstrated superior drug release. The tablets were evaluated for friability, weight variation, wetting time, hardness, disintegration time and uniformity of content. Optimized formulations were evaluated for in vitro dissolution test. Amongst all the formulations F-6 was found to be most successful tablets prepared by this technique had disintegration time of 30sec and % CDR 94.78 within 30min. Hence, this advance can be utilized for taste masking of bitter pharmaceutical ingredients leading to superior patient compliance. Keywords: Oral disintegration tablets, Lornoxicam, Kyron T-114, Superdisintegrants, Direct Compression.

Formulasi Fast Disintegrating Tablet Ekstrak Etanol Daun Salam dengan Kombinasi Crospovidone dan Croscarmellose Sodium sebagai Superdisintegrants

Pengembangan formulasi ekstrak daun Salam (Syzygium polyanthum W.) sebagai antihiperlipidemia yang mampu hancur cepat setelah diletakkan di atas lidah sangat diperlukan untuk mempercepat onset obat dan memberikan kenyamanan terutama pada pasien hiperlipidemia usia lanjut yang sulit menelan obat. Tujuan dari penelitian ini untuk mengetahui komposisi perbandingan superdisintegrants crospovidone dan croscarmellose sodium yang mampu menghasilkan sifat fisik Fast Disintegrating Tablet (FDT) yang optimum. Pembuatan FDT menggunakan metode granulasi basah dengan variasi konsentrasi crospovidone dan croscarmellose sodium dalam rentang 2%-5%. Hasil uji sifat fisik FDT dianalisis menggunakan metode Simplex Lattice Design (SLD) program Design Expert 10.1.). Kombinasi kedua superdisintegrants dapat mempengaruhi respon sifat fisik yaitu mampu menurunkan kekerasan, waktu disintegrasi, waktu pembasahan dan meningkatkan kerapuhan FDT ekstrak daun salam. Formula optimum didapat pada kombinasi crospovidone dan croscarmellose sodium dengan perbandingan 25 mg : 10 mg dalam setiap 500 mg tablet. Formula optimum tersebut memiliki kekerasan 4,21 kg, kerapuhan 0,52%, waktu pembasahan 106,65 detik, dan waktu hancur 55,73 detik. Hasil analisis dengan one sample t-test menunjukkan persamaan SLD valid digunakan untuk menyusun formula yang memberikan parameter-parameter optimum FDT.

Formulation and Evaluation of Orodispersble Tablet

The aim of present work is to formulate and develop tablets of promethazine HCL.by using various superdisintegrating agent by direct compression method. The main objective of the study is to increase rapid onset of action of promethazine HCL in the treatment of nausea and vomiting. The orodispersible tablet of promethazine hcl is were prepared by direct compression method. Using different concentration of Crospovidone, croscarmellose sodium Mannitol, lactose, maltose, mg. stearate. The tablet was evaluated by various parameters and result are found to be satisfactory.

Formulation and Evaluation of Ibuprofen Fast Dissolving Tablets Employing Starch Malonate (Modified Starch) as a Superdisintegrant

Aim: The goal of the study was to prepare a superdisintegrant named starch malonate followed by its evaluation for physicochemical properties. Prepared starch malonate was optimized in the preparation of fast dissolving tablets of ibuprofen by using 23 factorial designs. Methods: Compatibility studies like FTIR, TLC and DSC were performed to check any interaction between starch malonate and ibuprofen. Fast dissolving tablets were compressed by direct compression method and subjected to various official tests like hardness, friability, drug content, dissolution etc. Wetting time and water absorption ratio were also performed. At last response surface plot and contour plot was plotted to check the effects of starch malonate, croscarmellose sodium and crospovidone (independent variables) on disintegration time and dissolution efficiency in 5 minutes (dependent variables). Stability studies were also performed to check the stability of prepared fast dissolving tablets of ibuprofen. Results: Results of the studies showed that all the results are within acceptable limits and complying with the criteria of fast dissolving tablets. Drug content was found to be (100±5%), hardness of all tablets were found in between 3.8 -4 kg/cm2, friability was found less than 0.15%. Optimized formulation has showed less wetting time, less disintegration time followed by enhanced drug release. Among all formulation, formulation F2 has shown least disintegration time and enhanced drug release (99.89%) as compared to other formulations. We can conclude that starch malonate can be used as a novel superdisintegrant.

Formulation development and evaluation of Orally Disintegrating Tablets Rizatriptan Benzoate

Formulation research is oriented towards safety, efficacy and quick onset of action of existing drug molecule through novel concepts of drug delivery. Orally disintegrating tablets of Rizatriptan benzoate were prepared by direct compression method to provide faster relief from pain to migraine sufferers. About eleven formulations for the present study were carried out. Croscarmellose sodium, Crospovidone and Sodium starch glycolate (SSG) were used as superdisintegrants, while microcrystalline cellulose was used as diluent. The prepared batches of tablets were evaluated for weight variation, hardness, friability, wetting time, invitro dispersion time, drug content and invitro dissolution studies. The formulation containing combination of Croscarmellose sodium and Sodium starch glycolate showed rapid invitro dispersion time as compared to other formulations. The optimized formulation dispersed in 8 seconds. It also showed a higher water absorption ratio and 99.58% of drug is released within 2 minutes.

Formulation and Evaluation of Mouth Dissolving Tablet of Almotriptan Malate

Mouth dissolving tablet disintegrates and dissolves rapidly in the saliva, within a few seconds without the need of drinking water or chewing. A mouth dissolving tablet usually dissolves in the oral cavity within 15 seconds to 3 minutes. Almotriptan malate is an anti migraine drug with bitter taste and shows hepatic metabolism. In the present work, Mouth dissolving tablets of almotriptan malate were prepared by direct compression method using sodium starch glycolate and croscarmellose sodium as superdisintegrant with a view to enhance patient compliance and to avoid gastric dysmotility which is common with migraine drugs and for fast action of drug. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water-absorption ratio and in-vitro dispersion time. Short-term stability studies on the promising formulation indicated that there are no significant changes in drug content and disintegration time. Keywords: Almotriptan malate, Superdisintegrant, Sodium starch glycolate, Crosscarmellose sodium, Taste masking.

Quality-by-Design Approach and Optimization of Risk Factors by Box-Behnken Design in Formulation Development of Aspirin and Glycine Orally Disintegrating Tablet

Quality-by-design approach (QbD) was applied to develop an orally disintegrating tablet (ODT) formulation of aspirin and glycine. At first, the target quality profile and critical quality attributes (CQAs) of the product were identified. Risk assessment was accomplished by failure mode and effects analysis (FMEA) method to assess the factors having a significant effect on CQAs like disintegration time (DT), friability and assay of aspirin and glycine. Low substituted hydroxypropyl cellulose (L-HPC), croscarmellose sodium (CCS) and punch-diameter were found critical for DT and friability. The box-Behnken design was applied to optimize those 3 factors to reach a target DT of ≤ 30 sec. It was found that a punch-diameter between 8.7 ~ 9.3 mm, CCS in a range of 4 % ~ 5 %, and L-HPC in a range of 2 % ~ 8 % produced the best oral disintegrating property and reduced the risk. In summary, this work represented an excellent example of the application of QbD approach in ODT formulation development.

FORMULATION AND EVALUATION OF PRAVASTATIN FAST DISINTEGRATING TABLETS USING NATURAL SUPERDISINTEGRANT

The basic concept of FDT is the incorporation of superdisintegrants, which promotes breakdown of tablet quickly when kept or positioned on the tongue, allowing the drug to be released into the saliva. The rate of absorption is regulated by the solubility of the medication. The faster the dosage form of the medication dissolves in solution, the faster the therapeutic action is absorbed and initiated. In FDT, a medicine or dose form should dissolve or disintegrate in the saliva within 60 seconds. The objective of this research work is to formulate a Pravastatin tablet that disintegrated quickly using natural disintegrants. As a diluent, we employed microcrystalline cellulose. Synthetic superdisintegrant such as crospovidone and croscarmellose sodium were used, they were replaced with natural superdisintegrant. In this study, natural superdisintegrant dehydrated banana powder were used synthetic superdisintegrants viz. croscarmellose sodium, crospovidone. A Natural superdisintegrant was used in this formulation at concentrations of 2, 4, 6 and 8% of total weight of tablet i.e. 4, 8, 12 and 15 mg respectively in 200 mg tablet. According to the data, the tablet formulation containing 6% banana powder (i.e., 12 mg per tablet, formulation code FB4) showed a faster and higher drug release of 97.75% during the in-vitro dissolution investigation.

DESIGN, OPTIMIZATION AND EVALUATION OF ACECLOFENAC FAST DISSOLVING TABLETS EMPLOYING STARCH VALERATE–A NOVEL SUPERDISINTEGRANT

Objective: To synthesize, characterize and evaluate starch valerate as a superdisintegrant in the formulation of aceclofenac fast dissolving tablets by employing 23 factorial design. Methods: Starch valerate was synthesized and its physical and micromeritic properties were performed to evaluate it. The fast dissolving tablet of aceclofenac was prepared by employing starch valerate as a superdisintegrant in different proportions in each case by direct compression method using 23 factorial design for evaluation of tablet parameters like disintegration and dissolution efficiency in 5 min. Results: The starch valerate prepared was found to be fine, amorphous and free flowing. Starch valerate exhibited good swelling in water with swelling index (125.2%). The study of starch valerate was shown by fourier transform infrared spectra (FTIR). The drug content (200±5%), hardness (3.5–4 kg/sq. cm), and friability (<0.15%) has been effective with regard to all the formulated fast dissolving tablets employing starch valerate. The disintegration time of all the formulated tablets was found to be in the range of 14±0.04 to 25.7±0.02 sec. The optimized formulation F4 had the least disintegration time i.e., 12.8±0.02 sec. The wetting time of the tablets was found to be in the range of 76±0.21 to 217±0.17s. The In vitro wetting time was less (i.e., 28±0.02s) in optimized formulation F4. The water absorption ratio of the formulated tablets was found to be in the range of 46±0.12 to 100±0.27%. The percent drug dissolved in the optimized formulation F8 was found to be 99.93% in 5 min. Conclusion: Starch valerate, when combined with sodium starch glycolate, croscarmellose sodium, with aceclofenac, was found to be an effective super disintegrant which improved the dissolution efficiency and could therefore be used in the formulation of quick dissolving tablets to provide immediate release of the contained drug within 5 min.