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Buccal tablets
Diclofenac sodium
Drug release
Mucoadhesion
Mucoadhesive tablets
Release kinetics
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Objective: The aim of the present study was to prepare the ondansetron hydrochloride Mouth Dissolving Tablets (MDTs) followed by its comparison with ethical and non-ethical (generic) marketed tablets. Methods: Prior to the formulation, drug excipient compatibility study was carried out by FTIR spectroscopy. The λmax was determined by UV spectroscopy. The ondansetron hydrochloride MDTs were prepared by direct compression method using Sodium Starch Glycolate (SSG) as super disintegrant and camphor as a sublimating agent. Then the prepared MDTs were subjected to evaluation of post compression parameters such as thickness and diameter, weight variation, wetting time, hardness, friability, disintegration and dissolution. The results obtained were compared with that of ethical and non-ethical marketed ondansetron hydrochloride 4 mg tablets. Results: The λmax was found at 310 nm. FTIR study revealed that excipients used in the prepared formulations are compatible with the drug. The thickness and diameter was in the range of 2.646 to 3.27 mm and 6.0 to 8.12 mm, respectively. Friability was in the range of 0.43 to 0.88 % and had a slightly higher friability (1.27%) for sublimated tablets. Wetting time and disintegration time were in the range of 15 to 40 sec and 23 to 50 sec, respectively. The 100 % drug release was found within 180 sec for all the codes. These results were then compared with non-ethical film coated ondansetron marketed tablets. Conclusion: Ondansetron hydrochloride MDT 4 mg tablets prepared in the laboratory were under specified IP limits. The experimental findings demonstrated that any of these ethical and non-ethical tablets of ondansetron hydrochloride can be selected, advised by the physician or pharmacist, as per the patient’s need and economical status.
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Objective:To optimize the formula of adefovir dipivoxil tablets and investigate the dissolution in vitro. Methods:The formula was optimized by the D-optimal mixture design, the effects of the amount of filler ( X1 ,%) , the amount of disintegrant agent ( X2 ,%) and the amount of binder ( X3 ,%) were selected as the independent variables, and the friability ( Y1 ,%) , disintegration time ( Y2 , min) and dissolution of adefovir dipivoxil ( Y3 ,%) were the dependent variables. The similarity of the self-prepared prepa-ration and the reference preparation was obtained by using f2 similarity factor. The stability of adefovir dipivoxil tablets was evaluated preliminarily by high temperature, high humidity and strong light testing. Results:The optimal formula of adefovir dipivoxil tablets was as follows:the amount of lactose monohydrate was 67. 0%, the weight of croscarmellose sodium was 8. 0% and the amount of pregelati-nized starch was 12. 0%. The prepared tablets had lower friability, shorter disintegration time and higher drug dissolution rate. The dissolution similarity factors of the self-prepared tablets and the reference preparation in four dissolution media were all greater than 50. The results of influencing factor tests showed that the product should be moisture preservation. Conclusion:The formula of adefovir dip-ivoxil tablets optimized by the D-optimal mixture design is similar to that of the reference preparation, and the preparation process is feasible, which can meet the requirements of large production.
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Paracetamol is a widely used analgesic and antipyretic drug worldwide. The present study was conducted to analyze the quality of seven marketed brands of paracetamol tablet formulation manufactured by different multinational and national companies. The tablet formulations of different brands were tested for various parameters like weight variation, hardness, friability, disintegration time and dissolution profile using standard techniques to evaluate their quality. The values were compared with the standards. Weight variation value requirement was complied by all brands. All studied samples except two local products complied with the standard specification for tablet hardness. All brands showed impressive friability values and products of multinational companies comparatively exhibited the highest values. Disintegration time for all brands was within 15 minutes also complying the USP (United State of Pharmacopeia) recommendation. Moreover, the release rate of different brands of paracetamol was satisfactory within 45 minutes and ranged from 79.82% to 103.53%. Therefore, it can be concluded that almost all the brands of paracetamol that are available in Bangladesh meet the USP specification for quality control analysis.
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Objective:To prepare and optimize the formula of metoclopramide orally disintegrating tablets, and investigate the in vitro drug dissolution behavior. Methods:The formula was optimized by full-factorial experiment design, the ratio of mannotil to micro-crystalline cellulose ( X1 ) and the amount of disintegrating agent ( X2 ,%) were selected as the independent variables, and the friabili-ty ( Y1 ,%) , disintegration time ( Y2 , s) and metoclopramide dissolution ( Y3 ,%) were used as the dependent variables. The release rate of metoclopramide orally disintegrating tablets in different dissolution media was studied. Results:The optimum formula of meto-clopramide orally disintegrating tablets was as follows:the ratio of mannotil to microcrystalline cellulose was 2. 5∶ 1, and the amount of disintegrating agent was 6. 5%. The dissolution of metoclopramide orally disintegrating tablets in the different dissolution media was o-ver 80%. Conclusion:The formula design is reasonable, the preparation process is feasible and the quality can be controlled.
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Objective:To prepare and optimize candesartan cilexetil tablets,and study the stability preliminarily. Methods:The formula was optimized by Box-Behnken experiment design,the ratio of lactose to pregelatinized starch( X1 ),the amount of disintegrant ( X2 ,%)and the amount of lubricant( X3 ,%)were selected as the independent variables,and weight difference( Y1 ,%),friability ( Y2 ,%),disintegration time( Y3 ,%)and candesartan cilexetil dissolution( Y4 ,%)were the dependent variables. The release rate of candesartan cilexetil tablets and the reference tablets were compared by similarity factor( f2 value). Preliminary stability was studied by high-temperature test,high-humidity test and illumination test. Results:The optimal formula of the tablets was as follows:the ratio of lactose to pregelatinized starch was 7:1,the amount of disintegrant was 5. 5%,and the amount of lubricant was 0. 5%. The f2 for the candesartan cilexetil tablets and the reference tablets in different dissolution meda was 60. 62,73. 34,66. 95 and 68. 60,respec-tively. Conclusion:The formula design is reasonable,the preparation process is feasible and the quality can be controlled.
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Paracetamol is a widely used analgesic and antipyretic drug worldwide. The present study was conducted to analyze the quality of seven marketed brands of paracetamol tablet formulation manufactured by different multinational and national companies. The tablet formulations of different brands were tested for various parameters like weight variation, hardness, friability, disintegration time and dissolution profile using standard techniques to evaluate their quality. The values were compared with the standards. Weight variation value requirement was complied by all brands. All studied samples except two local products complied with the standard specification for tablet hardness. All brands showed impressive friability values and products of multinational companies comparatively exhibited the highest values. Disintegration time for all brands was within 15 minutes also complying the USP (United State of Pharmacopeia) recommendation. Moreover, the release rate of different brands of paracetamol was satisfactory within 45 minutes and ranged from 79.82% to 103.53%. Therefore, it can be concluded that almost all the brands of paracetamol that are available in Bangladesh meet the USP specification for quality control analysis.
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Banana starch obtained from unripe fruits of Musa sapientium L. has been evaluated as disintegrant in comparison with official corn starch. The physicochemical and material properties of the starches were evaluated and the properties of paracetamol tablet prepared by wet granulation using the starches as endo-disintegrants were determined. The results indicated that the physicochemical and material properties of banana starch varied considerably from corn starch. Scanning electron microscopy showed that banana starch granules were oval or ellipsoidal in shape while corn starch granules were angular or polyhedral in shape. The crushing strength (CS) of paracetamol tablets increased with disintegrant concentration while friability decreased. Tablets containing banana starch exhibited higher CS but lower friability than those containing corn starch. Paracetamol tablets containing banana starch had longer disintegration times than those containing corn starch although there were no significant (p >0.05) differences in the disintegration time of tablets. The results showed that banana starch compared well with corn starch as disintegrant.
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Aims: To evaluate the effect of mucilages of natural and pregelatinized forms of trifoliate yams, rice and official corn starch binders on a paracetamol tablet formulation. Methodology: Natural starches from two trifoliate yam varieties, and rice were isolated and pregelatinized. Both starch forms were then incorporated into a paracetamol tablet formulation as binders. The influence of the binders on compaction of granules and quality of tablets was assessed. Particle, bulk and tapped densities were measured for all the batches of the prepared paracetamol granules. The Heckel and Kawakita plots from which mean yield pressure, Py and another pressure term Pk, which indicates the pressure required to reduce the volume of the granule bed by 50%, were derived respectively. Both were employed to assess the compaction behaviour of the granules. Quality of the compressed tablets was studied using tensile strength, friability, disintegration time and dissolution properties as evaluation parameters. Results: Pregelatinized starch mucilages generally show lower values of both Py and Pk than natural starch mucilages. Increased concentration of starch mucilage binder also yielded lower values of both Py and Pk. Tablets containing natural starches exhibited higher Tensile strength and lower friability than those formulated with pregelatinized starch binders. Generally, Disintegration time (Dt) and the time taken for 80 % paracetamol to be released (t80) were higher for formulations containing natural starch binders than those containing pregelatinized binders The drug dissolution rate constants k1 and k2, were higher for formulations containing pregelatinized binders. Conclusion: The results obtained are suggestive of the fact that the use of mucilage of pregelatinized starch (rather than natural starch), as well as increase in concentration of the material, would yield formulations with faster onset of plastic deformation as well as higher total plastic deformation. The experimental starches compared well with the standard official corn starch and may thus be developed as substitutes in some tablet formulations.
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Quality of pharmaceutical product is very important because drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. The evaluation of the physical characteristics of the pharmaceutical products can ensure their quality as well as bioavailability and impart optimum therapeutic activity. Ketorolac tromethamine was chosen for this comparative study because this drug is widely used worldwide for treating moderate to severe pain. The present study compared the weight variation, hardness and the abrasion withstanding ability of eight brands of Ketorolac tromethamine tablets marketed in Bangladesh following USP guidelines. All eight brands of Ketorolac tromethamine tested conformed to the USP weight variation test. All the brands had average hardness of ≥3 kg which was satisfactory for immediate release tablet like ketorolac tromethamine. All the brands had shown their friability variation within ±1% range specified by USP. Standard deviation was calculated among all the brands which was very close to individual percentage friability of all the brands. All the brands of ketorolac tromethamine complied with USP requirements of physical quality parameters. It follows that these brands will show good disintegration and dissolution profile which would further help in achieving optimum bioavailability and in fulfilling the patient demands.
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OBJECTIVE:To obtain an optimum formulation of clarithromycin dispersible tablets METHODS:The preparation process was set by way of screening formulation and a formula with substitution of LS-HPC for starch was adopted RESULTS:The results showed that the substitution of LS-HPC for starch was the most preferable formulation The hardness and the friability of the tablets were improved The external apperance of unfilled corner and torn edge of the unimproved tablets was resolved CONCLUSION:Modified formulation is favorable for improving the quality of the product