Formulation and Evaluation

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1 Chapter-5 Formulation and Evaluation 5.1 OBJECTIVE After successful taste masking and solubility enhancement of drugs in preliminary studies, by using Mannitol Solid Dispersion, next step includes the Formulation of Mouth Dissolving Tablets which can disintegrate and dissolve vary rapidly (within few seconds) and free from any rough texture. Objective of this study involves; a. Preliminary Formulation Trials: To identify suitable mechanism for rapid disintegration and dissolution of tablets and select the best excipients for final Formulation b. Formulation of Mouth Dissolving Tablets: To prepare the Mouth dissolving tablets by different methods (sublimation, effervescent) using selected excipients c. Evaluation of the Prepared Tablets: To evaluate the prepared MDTs for hardness and friability for its suitability to industrial use as well as disintegration and dissolution studies for quick and fast release of the drug. 5.2 MATERIALS Camphor, Menthol (Qualikems, New Delhi, India.), Sodium Bicarbonate, Calcium Carbonate Talc, Magnesium Stearate (RFCL Limited, New delhi), Citric Acid, Tartaric Acid, Glucose, Lactose (Nice Chemicals Pvt. Ltd., India) were purchased from the standard concern.. All other chemicals used were of analytical grade. 5.3 EQUIPMENTS UV Spectrophotometer (UV 1800, Shimadzu, Japan), USP Dissolution Apparatus (TDT 08L, Electrolab), Scanning Electron Microscope (JEOL 457 V, Japan), Rotary tablet Machine (Cadmach, D Tooling), Hardness Tester (Monsanto), Friabilator (Electrolab, India), DT Apparatus (Electrolab, India), Digital Balance (Shimadzu, Japan), Vortex shaker (Electro Lab, India), Water bath incubator shaker (Tanco Pvt. Ltd., India), Vaccum Oven (Q5247, Navyug, India) were used. Department of Pharmaceutical Sciences, M. M. University, Mullana 72

2 5.4 PRELIMINARY FORMULATION TRIAL Two type of preliminary formulation trials were carried out. a. Preliminary Disintegration Trials: Various disintegration mechanisms were tried to find out best suitable quick disintegration mechanism to fulfill the requirement of the desired MDTs with minimum moisture gain and disintegration time along with negligible insoluble residue. i) Swelling and Deformation: works on the mechanism that disintegrating agent swells upon water absorption, breaks the tablet matrix due to induced localized stress within the tablet. On this mechanism two trial were selected Use of Superdisintegrant Use of Pregelatinized Starch ii) Porosity and Capillary Action (Wicking): by increasing the porosity in the tablet, the fluid tends to rupture the tablet by capillary action. Sublimation iii) Release of Gas: Interaction between Sodium bicarbonate and Tartaric acid produces carbon dioxide which generates pressure within the tablet and causes the disintegration of the tablet Effervescent b. Excipients Screening Trials: carried out to select the excipients for preparation of tablets i) Water Soluble excipients: Mannitol, Glucose and Lactose ii) Effervescent Excipients: Calcium Carbonate, Sodium Bicarbonate, Tartaric Acid, Citric Acid Department of Pharmaceutical Sciences, M. M. University, Mullana 73

3 5.4.1 Preliminary Disintegration Trials Use of Superdisintegrant: Superdisintegrant facilitates rapid disintegration and drug dissolution at very low concentration added in tablets. So Commonly used Superdisintegrant ncluding Sodium Starch Glycolate (SSG), Microcrystalline Cellulose (MCC), Croscarmellose Sodium (CCS) were used for preliminary screening Table 5.1 Composition of Formulation Trials using Superdisintegrant S.N Ingredients Trial A Trial B Trial C Trial D Trial E Intra granular Agents 1 Drug* (mg) Mannitol (mg) SSG (mg) MCC (mg) CCS (mg) Granulating agent 6 Starch Paste Q.S Q.S Q.S Q.S Q.S Extra granular agents 7 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 8. Total (mg) Observations 9 Moisture Gain D.T (min.) Insol. Residue *Drug Mannitol Solid Dispersion (1:4), SSG-Sodium Starch Glycolate, MCC-Micro Crystalline Cellulose, CCS-Croscarmellose Sodium Observation: Formulation trails (A to E) shows low disintegration time but gives insoluble residue after disintegration and dissolution with rough texture. So does not fulfill the basic requirement of MDTs. Department of Pharmaceutical Sciences, M. M. University, Mullana 74

4 Use of Pregelatinized Starch Pregelatinized starch, a directly compressible form of starch consisting of intact and partially hydrolyzed ruptured starch grains has multiple uses including Disintegrant (mechanism of action is thought to be through swelling). Table 5.2 Composition of Formulation Trials using Pregelatinized starch S.N Ingredients Trial A Trial B Trial C Trial D Trial E Intra granular Agents 1 Drug* (mg) Mannitol (mg) Pregelatinized Starch (mg) Granulating agent 4 Starch Paste Q.S Q.S Q.S Q.S Q.S Extra granular agents 5 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 6. Total (mg) Observations 7 Moisture Gain D.T (min.) Insol. Residue *Drug Mannitol Solid Dispersion (1:4) Observation: with increasing concentration of Pregelatinized starch in the formulation, the disintegration time decreases but increases the insoluble residue. Department of Pharmaceutical Sciences, M. M. University, Mullana 75

5 Sublimation Sublimation works on the mechanism of wicking by increasing the porosity in the tablet by incorporating a subliming agent (Camphor, Menthol) in the tablet followed by sublimation to give porous structure in the tablet thus increasing its disintegration and dissolution. Table 5.3 Composition of Formulation Trials using Sublimation S.N Ingredients Trial A Trial B Trial C Trial D Trial E Intra granular Agents 1 Drug* (mg) Mannitol (mg) Camphor Menthol Granulating agent 5 Starch Paste Extra granular agents 6 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 7. Total (mg) Observations 8 Moisture Gain D.T (min.) Insol. Residue *Drug Mannitol Solid Dispersion (1:4) Observation: with increasing concentration of subliming agent, porosity increases and disintegration time decreases with giving no insoluble residue, so finalized for MDTs preparation. Department of Pharmaceutical Sciences, M. M. University, Mullana 76

6 Effervescent In effervescent, sodium bicarbonate and tartaric acid was added separately in the formulation and in contact with fluid generate CO 2 which breaks the tablet Table 5.4 Composition of Formulation Trials using Effervescent S.N Ingredients Trial A Trial B Trial C Trial D Trial E Intra granular Agents 1 Drug* (mg) Mannitol (mg) NaHCO 3 (mg) Tartaric Acid (mg) Granulating agent 5 Sucrose Sol. Q.S Q.S Q.S Q.S Q.S Extra granular agents 6 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 7. Total (mg) Observations 8 Moisture Gain D.T (min.) <1 10 Insol. Residue *Drug Mannitol Solid Dispersion (1:4), NaHCO 3 = Sodium Bicarbonate Observation: with increasing concentration of Sodium Bicarbonate, rapid disintegration was observed (<1 min.), so finalized for MDTs preparation. Department of Pharmaceutical Sciences, M. M. University, Mullana 77

7 5.4.2 Excipients Screening Trials Water Soluble Excipients In this study, the various water soluble excipients (Glucose, Lactose, Mannitol and Sucrose) were selected to choose the best excipients for MDTs Table 5.5 Composition for Excipients screening Trials from Water soluble Excipients S.N Ingredients Trial A Trial B Trial C Trial D Trial E Intra granular Agents 1 Drug* (mg) Mannitol (mg) Glucose Lactose Sucrose Granulating agent 6 Sucrose Sol. Q.S Q.S Q.S Q.S Q.S Extra granular agents 7 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 8. Total (mg) Observations 9 Moisture Gain D.T (min.) Insol. Residue *Drug Mannitol Solid Dispersion (1:4) Observation: Out of various water soluble excipients, mannitol and combination of mannitol and sucrose shows least disintegration time. Thus mannitol was chosen for further study Department of Pharmaceutical Sciences, M. M. University, Mullana 78

8 Effervescent Excipients In effervescent excipient, sodium bicarbonate was tried to replace with calcium carbonate and tartaric acid with citric acid for better results. Table 5.6 Composition for Excipients screening Trials from Effervescent Excipients S.N Ingredients Trial A Trial B Trial C Trial D Trial E Intra granular Agents 1 Drug* (mg) Mannitol (mg) CaCo 3 (mg) NaHCo 3 (mg) Tartaric Acid(mg) Granulating agent 6 Sucrose Sol. Q.S Q.S Q.S Q.S Q.S Extra granular agents 7 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 8. Total (mg) Observations 9 Moisture Gain D.T (min.) Insol. Residue *Drug Mannitol Solid Dispersion (1:4), CaCO 3 = calcium Carbonate, NaHCO 3 = Sodium Bicarbonate Observation: Calcium Carbonate fails to decrease the disintegration time and also produced insoluble residue. Department of Pharmaceutical Sciences, M. M. University, Mullana 79

9 Effervescent Excipients Table 5.7 Composition for Excipients screening Trials from Effervescent Excipients S.N Ingredients Trial A Trial B Trial C Trial D Trial E Intra granular Agents 1 Drug* (mg) Mannitol (mg) CaCo 3 (mg) NaHCo 3 (mg) Citric Acid(mg) Granulating agent 6 Sucrose Sol. Q.S Q.S Q.S Q.S Q.S Extra granular agents 7 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 8. Total (mg) Observations 9 Moisture Gain 10 D.T (min.) Insol. Residue *Drug Mannitol Solid Dispersion (1:4), CaCO 3 = calcium Carbonate, NaHCO 3 = Sodium Bicarbonate Observation: Citric Acid in replacement to the Tartaric acid give better results in case of Disintegration time and also suit with most of the flavours and sweetners in comparison to the tartaric acid. Department of Pharmaceutical Sciences, M. M. University, Mullana 80

10 5.5 FORMULATION OF MOUTH DISSOLVING TABLETS (MDTs) In Preliminary formulation trails, Superdisintegrant and Pregelatinized starch gives rough texture with insoluble residue. Sublimation and Effervescent were finalized for MDTs preparation due to very quick disintegration and lack of insoluble residue. Mannitol was found most suitable excipient due to its complete solubility and easy compressibility. In Effervescence, Citric Acid was preferred in place of tartaric acid due to its suitability to most of citrus flavors along with its taste. So for quick disintegration and complete dissolution of tablet, MDTs with following two methods were finalized for further study 1. By sublimation method Subliming agent (Camphor) in different ratio was added into formulation followed by sublimation. Prepared sublimed tablet was further evaluated. 2. By effervescent method Sodium bicarbonate and citric acid was used and MDTs were formulated by three methods to minimize the moisture gain by the formulation. a. By direct compression method b. By wet granulation method and c. Modified wet granulation method MDTs of Levocetirizine dihcl were prepared by these methods, evaluated and the optimized method was used for the preparation of the MDTs of the Cefixime. Department of Pharmaceutical Sciences, M. M. University, Mullana 81

11 5.5.1 Formulation of MDTs of Levocetirizine by Sublimation Method Camphor as subliming agent was added in different ratios (10:0, 9:1, 8:2, 7:3 and 6:4w/w) with mannitol was optimized (table 5.8) Table 5.8 Composition of Formulation of MDTs of Levocetirizine by Sublimation S.N Ingredients S1 S2 S3 S4 S5 1 Drug* (mg) Mannitol (mg) Camphor (mg) Lubricant (w/w) 0.1% 0.1% 0.1% 0.1% 0.1% 5 Total (mg) Observations 6 Moisture Gain D.T (min.) <1 8 Insol. Residue *Drug Mannitol Solid Dispersion (1:4) Methodology: All the ingredients (weighed and sieved through # 85) were thoroughly mixed in modified rotary flask shaker (inclined at 30 0 ) along with drug complex. The uniformly mixed mass mixed with 0.1% lubricant was directly compressed into tablet of average weight 250mg in a rotary compression machine (Cadmach model, 8mm punch diameter). The prepared tablet were weighed and subjected to sublimation using vacuum oven at 600mm Hg negative pressure at 80 0 C for 2 hours and weighed to check complete elimination of Camphor. After complete elimination, the MDTs were subjected to evaluation. Department of Pharmaceutical Sciences, M. M. University, Mullana 82

12 5.5.2 Formulation of MDTs of Levocetirizine by Effervescent Method Quantity of citric acid was kept constant and sodium bicarbonate was varied. MDTs were formulated by using following composition. Table 5.9 Composition of Formulation of MDTs of Levocetirizine by Effervescent S.N Ingredients D1/W1/E1 D2/W2/E2 D3/W3/E3 D4/W4/E4 D5/W5/E5 Intra granular agents 1 Drug* (mg) Mannitol (mg) NaHCo 3 (mg) Citric Acid (mg) Granulating agent 6 Sucrose (mg) Extra granular agents 7 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 8. Total (mg) *Drug Mannitol Solid Dispersion (1:4), NaHCO 3 = Sodium Bicarbonate Methodology 1 (Direct Compression Method): All the ingredients except effervescent material are passed through #85 and divided in two equal parts. Sodium bicarbonate and citric acid was added separately in different parts and then mixed with 0.1% Lubricant. Tablet of average weight 250mg were compressed. Observation: In this method, mixture becomes slightly moistened during mixing of two parts before compression and produce moistened tablet after compression. Table 5.10 Observation of MDTs by Direct Compressed Effervescent tablet Observation D1 D2 D3 D4 D5 1 Moisture Gain D.T (min.) Insol. Residue Department of Pharmaceutical Sciences, M. M. University, Mullana 83

13 Methodology 2 (Wet Granulation Method): All the ingredients except effervescent material are passed through #85 and divided in two equal parts. Sodium bicarbonate and citric acid was added separately and granules are prepared separately using sucrose as binder and dried followed by mixing with 0.1% Lubricant. Tablet of average weight 250mg were compressed. Observation: In this method, tablets fail to disintegrate as gas was released from the sodium bicarbonate during wet granulation step. Table 5.11a Observation of MDTs of Effervescent tablet by Wet Granulation Method Observation W1 W2 W3 W4 W5 1 Moisture Gain D.T (min.) Insol. Residue Methodology 3 (Modified Wet Granulation Method): All the ingredients except Sodium Bicarbonate are passed through #85 and mixed. Granule are prepared using sucrose as binder and dried. Granules are mixed with Sodium Bicarbonate and 0.1% Lubricant. Tablet of average weight 250mg were compressed. Observation: In this method, tablets shows least disintegration time and does not absorb moisture. So this method was finalized for preparation of MDTs of Cefixime. Table 5.11b Observation of MDTs of Effervescent by Modified Wet Granulation Method Observation E1 E2 E3 E4 E5 1 Moisture Gain D.T (min.) Insol. Residue Department of Pharmaceutical Sciences, M. M. University, Mullana 84

14 5.5.3 Formulation of MDTs of Cefixime by Effervescent Method MDTs of Cefixime were prepared by effervescent method using modified wet granulation method Table 5.12 Composition of Formulation of MDTs of Cefixime S.N Ingredients C1 C2 C3 C4 C5 Intra granular agents 1 Drug (mg) Mannitol* (mg) Mannitol (mg) NaHCo 3 (mg) Citric Acid (mg) Granulating agent 6 Sucrose (mg) Extra granular agents 7 Lubricant 0.1% 0.1% 0.1% 0.1% 0.1% 8. Total (mg) Observations 9 Moisture Gain D.T (min.) <1 <1 11 Insol. Residue *Drug Mannitol Solid Dispersion (1:4), NaHCO 3 = Sodium Bicarbonate Methodology: All the ingredients except Sodium Bicarbonate are passed through #85 and mixed. Granule are prepared using sucrose as binder and dried. Granules are mixed with Sodium Bicarbonate and 0.1% Lubricant. Tablet of average weight 650mg were compressed. Department of Pharmaceutical Sciences, M. M. University, Mullana 85

15 5.6 EVALUATION Hardness, Friability, Weight variation, content uniformity: a. Hardness The crushing strength (Kg/cm 2 ) of prepared tablets was determined by using Monsanto tablet hardness tester. Six tablets from each batch were selected and evaluated for crushing strength and average value with standard deviation was determined. b. Friability Friability of Tablets was performed in a Roche Friabilator (Electrolab, India). Twenty tablets from each batch were weight together and placed in the friabilator (25rpm). The friabilator was operated for 100 revolution and determine the friability (mass per cent of the lost mass with respect to the initial mass) c. Weight Variation Twenty tablets from each batch were weighed individually and the average weight was calculated. From the average weight of the prepared tablets, the standard deviation and individual deviation were determined. d. Content Uniformity Twenty tablets were weighed and powdered. The powdered tablet equivalent to drug was taken and kept in 100ml of distilled water in a 250ml flask and was placed on flask shaker for 24 hours and further after 12 hours standing, filtered, diluted and analyzed using UV Visible spectrophotometer (UV 1800, Shimadzu, Japan) In vivo Mouth Disintegration Study In vivo dissolution study was carried out by sensory test in human subjects described by (Kimura et al (1992) with a minor modification. For this study, four healthy volunteers (protocol IEC/21 approved by the Institutional Ethical Committee, M.M. University, Mullana and informed consent was obtained from the volunteers) took one tablet at random times and each volunteer licked (without biting) the tablet Department of Pharmaceutical Sciences, M. M. University, Mullana 86

16 without drinking water. The time (in seconds) required for complete dissolution of the tablet was informed by the human subject and reported In vitro disintegration time For In vitro disintegration time study of mouth dissolving tablets, no method is available, as these tablets have to disintegrate and dissolve within few minutes. Therefore, a modified method was used for in vitro disintegration study of mouth dissolving tablets. In this method, the dosage form was dropped in a beaker containing 50ml of water and the time required for complete disintegration of the dosage form was noted. The whole process was visualized through camera. For better visualization 1% methylene blue was added in the disintegration medium. The disintegration of formulation was also visualized under the microscope also In vitro Drug Release Studies In vitro dissolution study was carried out in two different medium. a. In simulated saliva (at ph 6.2): In vitro drug release study was carried out using modified basket method 10 atul in which 100ml beaker containing 50ml of simulated saliva solution was used and prepared tablets were placed in the baskets (37 0 C±1 0 C, 50rpm). The withdrawn samples were analyzed using UV Visible spectrophotometer (UV 1800, Shimadzu, Japan) b. In 0.1N HCl (at Gastric ph 1.2): carried out using USP XXII type II (Electrolab, India) apparatus. (Table 5.13) Table 5.13 Parameter for in vitro Drug Release Study Parameter At Simulated Saliva At Gastric ph Method Modified Basket Method USP XXII type Dissolution 50 ml of simulated Saliva 500 ml of 0.1N Temperature 37 0 C±1 0 C 37 0 C±1 0 C RPM Sample taken 1ml 2ml Dilution factor 4 times 10 times Department of Pharmaceutical Sciences, M. M. University, Mullana 87

17 5.6 RESULT AND DISCUSSION Hardness, Friability, Weight variation, content uniformity In the prepared sublimed tablets (table 5.14a), all the formulation shows very good content uniformity (>96.5±0.53%) but MDTs have problem in Friability (>20% in batch S5) and Hardness (decreases with increase in the porosity). Table 5.14a Evaluation Parameters of the MDTs of Levocetirizine prepared by sublimation Parameters S1 S2 S3 S4 S5 Hardness (kg/cm 2 ) * 4.21± ± ± ± ±1.0 Friability (%) # 0.23± ± ± ± ±2.19 Drug content (%) 96.2± ± ± ± ±0.53 Av. Weight (mg) # 251.1± ± ± ± ±1.4 *mean S.D for six tablets, # mean S.D for twenty tablets By effervescent method, MDTs shows sufficient Hardness (>4kg/cm 2 ) with minimum friability (<0.7%) and also posses good content uniformity (>98.1±0.13%) and passes the weight variation test. Table 5.14b Evaluation Parameters of the MDTs of Levocetirizine prepared by Effervescent Parameters E1 E2 E3 E4 E5 Hardness (kg/cm 2 ) * 4.22± ± ± ± ±1.0 Friability (%) # Drug content (%) ± ± ± ±0.33 Av. Weight (mg) # 250.1± ± ± ± ±1.2 *mean S.D for six tablets, # mean S.D for twenty tablets For Cefixime MDTs, MDTs shows sufficient Hardness (>4.76kg/cm 2 ) with minimum friability (<0.57%) and also posses good content uniformity (>97.3±2.33%). Department of Pharmaceutical Sciences, M. M. University, Mullana 88

18 Table 5.15 Evaluation Parameters of the MDTs of Cefixime prepared by Effervescent Parameters C1 C2 C3 C4 C5 Hardness (kg/cm 2 ) * 4.87± ± ± ± ±1.3 Friability (%) # Drug content (%) ± ± ± ±0.89 Av. Weight (mg) # 650.2± ± ± ± ±3.1 *mean S.D for six tablets, # mean S.D for twenty tablets Batch C4 was finalized for animal studies due to sufficient Hardness, minimum friability with no moisture gain storage In vivo Mouth Disintegration Study In human study, in vivo mouth disintegration time was found less then minutes for all the formulations (S2-S5 and E2-E5) in comparison to the formulation (S1 and E1). Table 5.16 in vivo Mouth disintegration time of the MDTs of Levocetirizine Batch No. S1 S2 S3 S4 S5 Time (sec.) > 280 ± ± 9 38 ± 4 25 ± 6 17 ± 5 Batch No. E1 E2 E3 E4 E5 Time (sec.) > 280 ± ± ± 6 34 ± 2 15 ± 4 *mean S.D for six tablets, In vitro Disintegration Time The disintegration mechanism in beaker was visualized and photographs were taken (Fig. 5.1) and show that all the formulation disintegrates within one minute and show the complete dissolution of the formulation without shaking. The microscopic study of the disintegration shows that the formulation disintegrate quickly and the crystals of mannitol dissolves completely within seconds giving no residue (Fig 5.2) Department of Pharmaceutical Sciences, M. M. University, Mullana 89

19 5. Formulation and Evaluation Fig 5.1 in vitro disintegration photographs: after 1sec. (1), 10sec (2), 18sec (3), 24sec (4), 32sec (5), 45sec (6), 51sec (7), 58sec (8) Department of Pharmaceutical Sciences, M. M. University, Mullana 90

20 5. Formulation and Evaluation Fig 5.2 Microscopic CCD photographs of dissolution mechanism (A-L) Department of Pharmaceutical Sciences, M. M. University, Mullana 91

21 5.6.4 In vitro drug release studies: Levocetirizine MDTs prepared by Sublimation a. In simulated saliva (at ph 6.2) Table 5.17 Cumulative percentage drug dissolved vs. time profile of the sublimed MDTs of Levocetirizine in simulated saliva Time (min) Cumulative % Drug Dissolved S1 S2 S3 S4 S ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±1.2 mean S.D for six tablets Fig 5.3 in vitro drug release profile of sublimed MDTs of levocetirizine in simulated saliva Department of Pharmaceutical Sciences, M. M. University, Mullana 92

22 b. At Gastric ph Table 5.18 Cumulative percentage drug release vs. time profile of the sublimed MDTs of Levocetirizine in 0.1N HCl Time (min) Cumulative % Drug Dissolved S1 S2 S3 S4 S ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±0.1 mean S.D for six tablets Fig 5.4 in vitro drug release profile of sublimed MDTs of levocetirizine in 0.1N HCl Department of Pharmaceutical Sciences, M. M. University, Mullana 93

23 5.6.5 In vitro drug release studies: Levocetirizine MDTs prepared by Effervescent a. In simulated saliva (at ph 6.2) Table 5.19 Cumulative percentage drug release vs. time profile of the effervescent MDTs of Levocetirizine in simulated saliva Time (min) Cumulative % Drug Dissolved E1 E2 E3 E4 E ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±1.1 mean S.D for six tablets Fig 5.5 in vitro drug release profile of effervescent MDTs of levocetirizine (simulated saliva) Department of Pharmaceutical Sciences, M. M. University, Mullana 94

24 b. At Gastric ph Table 5.20 Cumulative percentage drug release vs. time profile of the effervescent MDTs of Levocetirizine in 0.1N HCl Time (min) Cumulative % Drug Dissolved E1 E2 E3 E4 E ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±0.1 mean S.D for six tablets Fig 5.6 in vitro drug release profile of effervescent MDTs of levocetirizine in 0.1N HCl Department of Pharmaceutical Sciences, M. M. University, Mullana 95

25 5.6.6 In vitro drug release studies: Levocetirizine MDTs prepared by Effervescent a. In simulated saliva (at ph 6.2) Table 5.21Cumulative percentage drug release vs. time profile of the effervescent MDTs of Cefixime in simulated saliva Time (min) Cumulative % Drug Dissolved C1 C2 C3 C4 C ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ±0.8 mean S.D for six tablets Fig 5.7 in vitro drug release profile of effervescent MDTs of Cefixime in 0.1N HCl Department of Pharmaceutical Sciences, M. M. University, Mullana 96

26 5.7 OUTCOMES a. Preliminary Formulation Trials: MDTs with superdisintegrants (using SSG, MCC) produces insoluble residue. For MDT Formulation, mannitol was found most suitable in comparison to Lactose and Glucose due to quick dissolution, palatable taste. Citric acid was found more palatable in comparison to tartaric acid as citric acid have additional benefits (best suited with citrus flavors, suppress the unpleasant taste) b. Formulation of Mouth Dissolving Tablets MDTs prepared by sublimation have the problems of hardness (<2 kg/cm 2 ) and friability (>10%) thus have not industrial adaptability. MDTs prepared by effervescent method have sufficient hardness (>4 kg/cm 2 ) and friability (<0.7%) and prepared by usual wet granulation (method 2) thus have very good industrial adaptability. c. Evaluation of the Prepared Tablets MDTs prepared by sublimation (batch S5) showed least disintegration time (less than 1min. without shaking), maximum in vitro dissolution rate (T 50% =1.5 min., T 90% = 4min.) and least in vivo mouth disintegration time (15+4 sec.) with porosity. MDTs prepared by effervescent method (Batch E4 and E5) shows least disintegration time (less than 1.5 min. without shaking), maximum in vitro dissolution rate (T 50% < 3min., T 90% < 8min.) and least in vivo mouth disintegration time (< 35sec) and batch E4 shows better patient compliance in comparison to batch E5 in respect of sour taste due to high conc. of sodium bicarbonate. MDTs of Cefixime: Batch C4 and C5 shows least disintegration time (less than 2 min. without shaking), maximum in vitro dissolution rate (T 50% < 2.5min., T 90% < 7.5min.). Formulation C4 was selected for animal study Department of Pharmaceutical Sciences, M. M. University, Mullana 97

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