Formulation and Evaluation of Fast Dissolving Tablets of Albendazole by Sublimation method
Sheetal Buddhadev1, Dr. Sandip Buddhadev2
1. Assist. Prof. Noble Pharmacy College, Junagadh
2. Associate Professor in Govt. Ayurved College, Junagadh
Recent developments in the dosage form technology resulted in the development of Fast dissolving tablets (FDTs) with improved patient compliance and convenience. FDTs are solid unit dosage forms, which disintegrate or dissolve rapidly in the mouth without chewing and water. Fast Dissolving tablets provide an advantage particularly for pediatric and geriatric populations who have difficulty in swallowing conventional tablets and capsules. The objective of the present study was to prepare the fast dissolving tablets of Albendazole. Albendazole is broad spectrum anthelmintic use against many helminthes. It is used for treatment of Threadworm, Hookworm, and Tapeworm. It has low bioavailability due to its first pass metabolism.
In the present work, Fast dissolving tablets of Albendazole were design with a view to provide a quick onset of action and a better dissolution rate and further improving the bioavailability of the drug. In this study, an attempt was made to fasten the drug release from the oral tablets by incorporating the super disintegrant and camphor/ammonium bicarbonate as subliming agents. The prepared fast dissolving tablets were subjected to pre-compression analysis and evaluated for hardness, weight variation, friability, wetting time, water absorption ratio and disintegration time. From the results of in vitro drug release studies, the formulation F9 exhibited fast release profile of about 98.20% in 16 min and disintegration time 65.60 sec when compared with other formulations. For the optimized formulation F9, the initial dissolution rate was 36.5% / 2 min. Fourier transform infrared spectroscopy studies revealed that there was no possibility of interactions between drug and excipients. The present study demonstrated potential for rapid absorption, improved bioavailability, effective therapy and patient compliance.
Key Words: Fast Dissolving tablets (FDTs), Albendazole, Super Disintegrant, Subliming agent.
Recent advances in Novel drug delivery systems (NDDS) aim to enhance safety and efficacy of drug molecule by formulating a convenient dosage form for administration and to achieve better patient compliance. One such approach is fast dissolving tablets 1-3. Fast dissolving tablets are gaining prominence as new drug delivery systems. These dosage forms dissolve or disintegrate in oral cavity within a minute without the need of water or chewing. Thus the absorption is faster and more complete than with conventional tablet.
These are not only useful in administration of drugs in pediatric and geriatric patients but in patients suffering from stroke, thyroid disorder, Parkinson’s diseases and multiple sclerosis, patients with nausea, vomiting and motion sickness. The advantages of fast dissolving tablets include easy manufacturing, accurate dosing and easy handling by patients, no requirement of chewing and water for swallowing. These dosage forms have been investigated for their potential in improving bioavailability of poorly soluble drugs through enhancing the dissolution profile of the drug and also for hepatic metabolism drugs 4-7.
The excipients employed in fast dissolving tablets are always hydrophilic in nature whereas drug may be either hydrophilic or hydrophobic. If the drug is hydrophilic, the dosage form is known as fast dissolving tablets otherwise if drug is hydrophobic it is known as fast disintegrating tablets. The various synonyms used for fast dissolving tablets include mouth dissolving tablets, orally disintegrating tablets, melt in-mouth tablets, porous tablets, or dispersible, quick dissolving and rapid disintegrating tablets.
The basic approach in development of fast dissolving tablets is the use of super disintegrant like Cross linked carboxymelhylcellulose (Croscarmellose), Sodium starch glycolate (Primogel, Explotab), Cross Povidone etc. which provide instantaneous disintegration of tablet after putting on tongue, thereby releasing the drug in saliva. Super disintegrants provide fast disintegration due to collective effect of swelling and water absorption by the formulation. Due to swelling of super disintegrant, the wetted surface of the carrier increases; this promotes the wettability and dispersibility of the system, thus enhancing the disintegration and dissolution. The various techniques used for manufacturing of rapidly disintegrating or dissolving tablets are Freeze drying, Spray drying, Molding, Mass extrusion, Melt granulation, Sublimation and Direct compression. [8-14].
Albendazole (ABZ), methyl [5-(propylthio)-1-H-benzimidazol-2yl] carba-mate, is a benzimidazol derivative with a broad spectrum of activity against human and animal helminth parasites. ABZ is effective in the treatment of echinococcosis, hydrated cysts and neurocysticercosis. [15-19].
Sublimation is one of these approaches in which a subliming agent and superdisintegrant are included into the formulation to achieve fast disintegration of tablets. Extremely fast disintegration of tablets would be required to increase the release of Albendazole from tablets for rapid absorption by the oral mucosal blood vessels. Therefore, an attempt to formulate Albendazole into fast dissolving tablets for oral administration would have potential for emergency treatment of Threadworm, Hookworm, and Tapeworm. This could be achieved by selecting the suitable superdisintegrants in the correct proportion in combination with camphor/ammonium bicarbonate as subliming agents. .
Material and Methods
Albendazole was obtained as a gift sample from Brasica Pvt. Ltd. Boisar (India). Crospovidone, Microcrystalline cellulose and Croscarmellose sodium were purchased from Curex Pharma, Jalgaon. Polyvinyl Pyrrolidone K30 was obtained as gift sample from Emcure Pharma, Pune and Mannitol, Aspartame were purchased from Merck Ltd, Mumbai, India. All chemicals and reagents used were of analytical grade.
DRUG – EXCIPIENT COMPATIBILITY STUDIES
Calibration of standard curve of Albendazole:
100 mg of Albendazole was weighed accurately and dissolved in 100 ml of phosphate buffer solution, pH 6.8 in 100 ml volumetric flask. From this suitable dilutions were made to get concentrations of 0.5- 15 μg respectively. The absorbance of each solution was measured by UV-visible spectrophotometer at 291 nm using the phosphate buffer solution pH 6.8 as blank.
Fourier Transformation Infra-Red (FTIR) Analysis
An FT-IR spectrophotometer was used for the infrared analysis of samples. About 4-5 mg of sample was mixed with dry potassium bromide (KBr) and the sample was examined at transmission mode over the wave number range of 4000-400 cm-1.
The first step in the rationale development of dosage form is pre-formulation study which involves an investigation of physicochemical properties of a drug substance alone and when combined with excipients. Pre-formulation studies on the obtained sample of drug include colour, taste, solubility analysis, melting point determination and compatibility study.
Angle of repose:
Angle of repose (θ) was determined by measuring the height (h), radius of the heap(r)) of the powder blend. A cut system funnel was fixed to a stand and bottom of the funnel was fixed at a height of 2 cm from the plane. Powder blend was placed in funnel and allowed to flow freely and measured the height and radius of the heap.
The bulk density of a powder is dependent on particle packing and changes as the powder consolidates. Apparent bulk density (gm/ml) was determined by pouring bulk powder into a graduated cylinder via a large funnel and measuring the volume and weight. Bulk density can be calculated by the following formula,
Tapped density (Dt):
Tapped density is the bulk density of a powder which has been compacted by tapping or vibration. Tapped density was determined by placing a graduated cylinder containing a known mass of powder on a mechanical tapping apparatus, which is operated for a fixed number of taps (100) or until the powder bed volume has reached a minimum. The tapped density was computed by taking the weight of drug in cylinder and final volume.
Hausner Ratio is an indirect index of ease of powder flow. It is calculated by the following formula,
Compressibility Index (Carr’s Index):
Another indirect method of measuring powder flow form bulk densities was developed by Carr. The percentage compressibility of a powder is a direct measure of the potential powder arch or bridge strength and stability. It is calculated according to the following equation,
Preparation of fast dissolving tablets
Fast dissolving tablets of Albendazole were pre-pared using sublimation method incorporating superdisintegrants like, Crospovidone (CP), Croscarmel-lose Sodium (CCS) and Sodium starch glycolate (SSG) and camphor/ammonium bicarbonate as subliming agent. Each of the superdisintegrants was used in three different proportions. Mannitol was used as diluent in quantity sufficient; talc as flow promoter and magnesium stearate as lubricant. Aspartame was used as sweetener. All the ingredients were passed through sieve no. 60 and mixed in geometric order. All the materials were directly compressible. So, this uniformly mixed blend was compressed into tablets using 12mm round flat-faced punch of the rotary tablet machine. Compression force was constant for all formulations as showed in Table 1. Sublimation was performed from tablets by keeping in hot air oven at 40ºC for 6 h. Total nine formulations were prepared and the composition of formulations was shown in Table 1.
Table 1: Formulation of Albendazole Fast Dissolving tablets.
|Sodium starch glycolate||–||–||–||8.75||17.5||26.25||–||–||–|
valuation of the Fast Dissolving tablets (FDT): [27-34]
Quality control tests for FDTs of all formulations were performed, and the average values were calculated. All the tablets were evaluated for different parameters as weight variation, hardness, friability, drug content, wetting time, water absorption ratio, disintegration time and in vitro dissolution study.
Twenty tablets were selected randomly from each batch and weighed individually on electronic balance (Shimadzu). The individual weighed is then compared with average weight for the weight variations.
The strength of tablet is expressed as tensile strength (kg/cm2). The tablet crushing load, which is the force required to break a tablet into pieces by compression. It was measured using a tablet hardness tester (Monsanto hardness tester). Three tablets from each formulation batch were tested randomly and the average readings were noted.
Friability of the tablets was determined using Roche Friabilator. This device consists of a plastic chamber that is set to revolve around 25 rpm for 4 min dropping the tablets at a distance of 6 inches with each revolution. Pre weighed sample of 20 tablets was placed in the friabilator and were subjected to 100 revolutions. Tablets were dusted using a soft muslin cloth and reweighed. The friability (F %) is given by the formula,
Twenty tablets were weighed and powdered. An amount of the powder equivalent to 10mg of Albendazole was dissolved in 100 ml of phosphate buffer solution, pH 6.8., filtered, diluted suitably and analyzed for drug content at 291nm using UV‐Visible spectrophotometer (Shimadzu1700, Tokyo, Japan).
Wetting time & water absorption ratio:
A piece of tissue paper folded twice was placed in a small petri dish (internal diameter = 6.5 cm) containing 6 ml of phosphate buffer solution, pH 6.8. A tablet was placed on the paper and time required for complete wetting was measured using a stop watch. The wetted tablet was then weighed. Water absorption ratio (R) was determined using following equation,
Wa = Weight of tablet after water absorption,
Wb = Weight of tablet before water absorption.
In vitro disintegration time:
10 ml of phosphate buffer solution, pH 6.8 was placed in a petridish of 10 cm diameter. The tablet was then carefully positioned in the center of the petridish and the time required for the tablet to completely disintegrate into fine particles was noted.
In- vitro disintegration time:
In-vitro disintegration times for Fast dissolving tablets of Albendazole were determined using USP disintegration test apparatus with 900 ml of phosphate buffer solution, pH 6.8 as medium maintained at a temperature of 37 ± 2°C. The time in seconds taken for complete disintegration of the tablets with no palpable mass remaining in the apparatus was measured.
Invitro drug release studies:
In vitro drug release of Albendazole fast dissolving tablets was determined using USP XXIII Dissolution Apparatus II (Paddle type) [Electrolab Tablet Dissolution Tester] at 50 rpm. The drug release profile was studied in 900 ml of phosphate buffer solution, pH 6.8 by maintaining at 37 ± 0.5º C. Aliquots of 5 ml of dissolution medium were withdrawn at specific time intervals and replaced by fresh media. The samples were measured by UV- visible spectrophotometer at 291 nm against the blank. The % drug release was calculated using an equation obtained from the calibration curve. The release studies were conducted in triplicate and the mean values were plotted versus time.
Stability studies: 
Stability studies were carried out for the optimized formulation according to ICH guidelines. An optimize formulation were sealed in Aluminium packaging coated inside with polyethylene, and samples were kept in humidity chamber (Remi, India) at 40°C and 75% RH for three month. At the end of the period, samples were analyzed for drug physical changes, properties, drug content and in vitro release studies.
RESULTS AND DISCUSSION
Calibration Curve for Albendazole:
Calibration curve of Albendazole was prepared in phosphate buffer solution, pH 6.8 at 291 nm. The absorbance values (mean of three determinations) with their standard deviations at different concentration in the range of 0.5-15 µg/mL. Drug was found to obey Lambert Beer’s law with the high value of R2 (0.9982) indicates linearity of the drug between 0.5-15 µg/ml.
Table 2: Calibration Curve Data of Albendazole in pH 6.8 phosphate buffer at 291 nm
|Concentration (µg/ml)||Absorbance* ± S.D
at 205.5 nm
Figure 1: Standard graph of Albendazole in pH 6.8 phosphate buffer at 291 nm
Pre-formulation studies of Albendazole:
The drug and the excipients interaction studies were evaluated by checking the physical appearance and by FT-IR analytical methods. The following preformulation studies were performed on Albendazole and excipients.
Table 3: Preformulation parameter of Albendazole
|Particle size (μm)||9.84|
|Angle of repose º||25.98± 0.28|
|Bulk density (g/cm3)||0.701± 0.02|
|Tap density (g/cm3)||0.828± 0.04|
|Carr’s index||15.338± 0.04|
|Hausner’s ratio||1.181± 0.01|
The present study was undertaken to formulate fast dissolving tablets of Albendazole by sublimation method using croscarmellose sodium, sodium starch glycolate & crospovidone as superdisintegrants; camphor & ammonium bicarbonate as subliming agents. Total nine batches were formulated (F1, F2, F3, F4, F5, F6, F7, F8 and F9). The prepared tablets were evaluated for various pre-compression and post-compression parameters and the results were shown in Table 4 & 5 respectively. FT-IR studies revealed that there was no interaction between the selected drug, superdisintegrants and other excipients.
The angle of repose of all the formulations was within the range of 25.47º±0.17 – 28º±0.22 These values indicate that the powder blend exhibited good flow properties. The bulk density was found in the range of 0.696±0.01 – 0.702±0.01 g/cm3. The tapped density ranged between 0.800±0.01 – 0.828±0.04 g/cm3. The Carr’s index and Hausner’s ratio of all the formulations existed in the range of 12.250±0.08 to 15.338±0.04 and 1.140±0.01 to 1.187±0.01 respectively. These values indicate that the prepared powder blend of FDTs exhibited excellent flow properties.
The tablets were evaluated for various post-compression parameters such as physical appearance, diameter, thickness, weight variation, hardness, friability and drug content. The prepared tablets of all the nine formulations were found to be smooth in texture; round and flat in shape. Weight variation values for all the nine formulations were found to be within the limits. Hardness for all the formulations was found to be from 3.09 ± 0.10 to 3.83 ± 0.12 kg/cm2. The friability was found in the range of 0.52±0.18 % – 0.69±0.18 % and drug content values in the range of 96.97±0.38% – 99.81±0.35%. These values indicate that the prepared FDTs passed the tests for friability and drug content. The wetting time for all nine formulations was found to be in the range of 35.11 sec to 40.22 sec. Water absorption ratios of all formulations were in the range of 141.68 ± 0.56 to 209.65 ± 0.89.
Figure 2: FTIR Spectrum of Pure Albendazole
Wetting time, in vitro dispersion time and water absorption ratio found to be faster for the formulation F9 containing sublimable agent camphor & superdisintegrant crosspovidone as compared to other formulations. According to the Pharmacopoeial standards, the dispersible tablet must disintegrate within 3 min. All formulated batches have shown less disintegration time i.e. 65.60 to 98.16 sec indicating suitability of formulation for fast dissolving tablet. The wetting time for all nine formulations was found to be in the range of 35.11 sec to 40.22 sec. Water absorption ratios of all formulations were in the range of 141.68 ± 0.56 to 209.65 ± 0.89. Wetting time, in vitro dispersion time and water absorption ratio found to be faster for the formulation F9 containing sublimable agent camphor & superdisintegrant crospovidone as compared to other formulations. According to the Pharmacopoeial standards, the dispersible tablet must disintegrate within 3 min. All formulated batches have shown less disintegration time i.e. 65.60 to 98.16 sec indicating suitability of formulation for fast dissolving tablet.
Table 4: Pre-compression parameters of Fast Dissolving Tablets of Albendazole
|Bulk Density (g/ml)*
|Tapped Density (g/ml)*||Carr’s index(%)*
|F1||25.8± 0.28||0.701± 0.02||0.828± 0.04||15.338± 0.04||1.181± 0.01|
|F2||26.7± 0.19||0.698± 0.01||0.822± 0.01||15.085± 0.11||1.178±0.02|
|F3||26.0± 0.16||0.695± 0.01||0.818± 0.01||15.037± 0.15||1.177± 0.01|
|F4||26.0± 0.21||0.696± 0.01||0.820± 0.01||15.122± 0.05||1.178±0.02|
|F5||26.5± 0.23||0.696± 0.01||0.820± 0.01||15.122±0.13||1.178±0.02|
|F6||25.4± 0.17||0.694± 0.02||0.824± 0.02||15.777± 0.14||1.187± 0.01|
|F7||27.3± 0.08||0.698± 0.01||0.812± 0.01||14.039± 0.14||1.163± 0.01|
|F8||28.0± 0.22||0.702± 0.01||0.800± 0.01||12.250± 0.08||1.140± 0.01|
|F9||25.4± 0.17||0.696± 0.01||0.820± 0.01||15.122± 0.05||1.178±0.02|
*Results are presented as Mean±SD
Table 5: Evaluation of Fast Dissolving Tablets of Albendazole
|Water absorption ratio
|Content uniformity Mean(%)
*Results are presented as Mean±SD
Figure 3: Bar diagram showing Disintegration time for Albendazole FDT formulations
Figure 4: Bar diagram showing wetting time for Albendazole FDT formulations
Figure 5: Bar diagram showing water absorption ratio for Albendazole formulations
In-vitro drug release studies:
The dissolution conditions used for studying the drug release from the Fast dissolving tablets of Albendazole were: Dissolution test apparatus: USP type II, speed: 50 rpm, stirrer: paddle type, volume of medium: 900 ml, volume withdrawn: 5 ml, medium used: phosphate buffer solution, pH 6.8, temperature: 37±0.5ºC, λmax: 291 nm. The in-vitro dissolution studies of all formulations (F1 to F9) were conducted and the results were presented in Table No. 6 & Figure 6. The amount of drug released from different formulations F1, F2, F3, F4, F5, F6, F7, F8 and F9 at end of 16 min were 83.35%, 85.5%, 86.96%, 75.65%, 76.85%, 78%, 85.15%, 89.5% 94.25% and 98.20%respectively. In case of formulations F1, F2 & F3, croscarmellose sodium was used as the superdisintegrant (2.5%, 5% and 7.5%) & camphor (7.5%, 10% & 12.5%) as the subliming agent. For formulations F4-F6, the superdisintegrant used was sodium starch glycolate (2.5%, 5% and 7.5%) & the subliming agent was ammonium bicarbonate (7.5%, 10% and 12.5%). In formulations F7-F9, crospovidone (2.5%, 5% and 7.5%) was used as the superdisintegrant & camphor (7.5%, 10% and 12.5%) as the subliming agent. The maximum drug release of 98.20% was obtained from formulation F9 (crospovidone 7.5% & camphor 12.5%) and minimum drug release of 75.65% shown by F4 (sodium starch glycolate 2.5% & ammonium bicarbonate 7.5%). Further, the initial dissolution rate for formulation F9 was 36.5% / 2 min. Results showed that the drug release from the formulations increased with increase in the amount of superdisintegrant and subliming agent added in each formulation. Formulation F9 showed faster drug release compared to all formulations due to formation of porous structure by sublimation of camphor.
Table 6: Drug release profiles for Albendazole Fast Dissolving Tablet (F1-F9)
Figure 6: Invitro Drug Release Profile of Fast Dissolving Tablets of Albendazole
A perusal of Table 7 indicated that the optimized batch F9 release kinetics followed diffusion model as the R2 values are 0.890 for Higuchi model kinetics and also obeys Hixson-Crowell Cube Root Law as showing R2 values near to unity. Hence the release mechanism was due to the diffusion of drug through the formulation.
Table 7: Drug Release Kinetics of optimized batch F9.
|Zero order||Y= -1.775x+59.73||0.623|
|First order||Y= -0.040x+1.851||0.886|
|Higuchi model||Y= 14.83x+16.20||0.890|
|Hixon crowel cube root model||Y= 0.074x+0.649||0.910|
From the results of stability study, it was observed that the optimized formulation F9 was stable for the three month at 400C, 75% RH as specified by the ICH guidelines. From the data, the formulation F9 is found to be stable under the conditions mentioned before since there was no significant change in the physical characterization, Hardness, Friability, disintegrations, dissolution, drug content and percentage amount of drug content. Thus, it was found that the Fast Dissolving tablet of Albendazole (F9) was stable under these storage conditions for at least three month.
Table 8: Stability study (40 °C/75%RH) of Optimized Batch F9
|Parameters||Before stability studies||After stability studies|
|Weight variation(mg) )||351.50±0.36||350.50±0.96|
|Invitro disintegrating time(sec)||65.60± 2.18||64.60± 1.18|
|Wetting time(sec)||35.11± 3.00||35.61± 2.00|
|Drug content (%)||99.69±1.65||99.26±1.35|
|Water absorption ratio||209.65±0.89||210.65±0.10|
Applying the similarity factor f2
Similarity factor f2 is used to check the similarity between release profile of optimized formulation before and after the stability testing. Its value is from 50 to 100, the value larger than 50 shows the similarities. For this purpose CPR of optimized formulation F9 of Fast Dissolving tablets of Albendazole before stability period was taken as a reference standard, while same formulation after stability period was taken as a test formulation.
Table 9: Comparison of release profile of Reference and Test formulation
|Optimized batch F9 before stability (Reference)||Optimized batch F9 after stability (Tested)|
Figure 7: Comparison of release profile of Reference and Test formulation
Dissolution studies shows there was no significant difference in dissolution data of formulations at initial and after specified storage period.
The calculated value for f2 was more than 50 which shows that there is similarity of release profile between reference and tested formulations. The in vitro drug release profiles of the formulation obtained before and after stability studies were compared (Figure 7). The profiles appeared to be almost super imposable.
Fast dissolving tablets of Albendazole were prepared by using different superdisintegrants (croscarmellose sodium, sodium starch glycolate & crospovidone) and subliming agents (camphor & ammonium bicarbonate) by sublimation method. A total of nine formulations were prepared. All the physical characteristics of the formulations were found to be well within the limits of official standards. All the formulations get disintegrated with in a time period of 98 sec, when tested for in-vitro disintegration time. Amongst all the formulations, formulation F9 containing crospovidone 20mg and camphor 40mg is fulfilling all the parameters satisfactorily and has shown fastest disintegration (65.60 sec), wetting time (35.11 sec) and higher % drug release (98.20%) as compared to other formulations. Overall, the results suggest that suitably formulated fast dissolving tablets of Albendazole containing camphor as a subliming agent (F9) can be achieved. Fast dissolving tablets disintegrated within few seconds without need of water; thereby enhance absorption leading to increased bioavailability. Thus, the present study demonstrated potential for rapid absorption, improved bioavailability, effective therapy and increased patient compliance.
The authors are grateful to Elam Pharma Pvt. Ltd., Ankleshwar for providing gift sample of Albendazole and S.D fine Chem. Ltd. for providing Croscarmellose sodium, Crospovidone and. sodium starch glycolate. Authors are also thankful to the Noble Group of Institution, Junagadh Gujarat, for providing the necessary facilities and requirements for the completion of research work successfully.
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