Evaluation of Aloe vera and Hibiscus rosa-sinensis mucilage as a binder in different Tablet Formulations
Ashwini S. Jadhav*, Avani K. Shewale, Dr. Mangesh A. Bhutkar
Department of Pharmaceutics Rajarambapu College of Pharmacy, Kasegaon, Maharashtra India- 415404
*Corresponding Author E-mail: shanavi845@gmail.com
ABSTRACT:
Natural binders like different starches, gums, mucilages dried fruits possess binding capacity as well as some other properties like disintegrant, filler, sustain release, and these natural polymers are much safer and economical than polymers like PVP. The aim of the work was to evaluate utility of Aloe vera and Hibiscus rosa-sinensis mucilage as a binder in different tablet formulations containing Paracetamol as a model drug. Comparative evaluation of the prepared Paracetamol tablets (using Aloe Vera and Hibiscus rosa-sinensis mucilage as a binder) with the tablets manufactured using Microcrystalline cellulose as a binder. The results of the study revealed that mucilage from Hibiscus rosa sinensis and Aloe vera when utilized as a novel binder exhibited appropriate drug release pattern for conventional oral tablets of Paracetamol. Thus, it can be concluded that Hibiscus rosa sinensis and Aloe vera mucilage may be used as a binder in tablet formulation and possess a high potential for substitution for other more expensive binders.
KEYWORDS: Aloe Vera, Hibiscus rosa-sinensis, Mucilage, Paracetamol, Microcrystalline cellulose.
INTRODUCTION:
Tablet is defined as solid pharmaceutical dosage form containing drug substance generally with suitable diluents and prepared by either compression or molding methods. The oral route of drug administration is the most important method of drug administration for systemic effects. The parenteral route of administration is important in treating the medical emergencies in which subject is comatose or cannot swallow and in providing various types of maintenance therapy.
Nevertheless, about 90% of all the drugs used to produce systemic effects are administered by the oral route. Among the drugs that are administered orally, solid dosage form represents the preferred class of product. Solid dosage form provides best protection to the drug against temperature, humidity, oxygen, light and stress during transportation and also ensures accuracy of dosage, compactness, portability, blandness of taste, and ease of administration. Although the basic medicinal approach for their manufacture has remained the same, tablet technology has undergone great improvement. Efforts are being made continually to understand more clearly the physical characteristics of powder compaction and the factors affecting the availability of the drug substance from the dosage form after oral administration. Tableting equipment continues to improve in both production speed and the uniformity of the tablets compressed. Although tablets frequently are discoid in shape, they also exist in several shapes such as round, oval oblong, cylindrical or triangular etc. They may differ greatly in size and weight depending on the amount of the dug substance present and the intended method of administration. They are divided in to two general classes by whether they are made by compression or molding. Compressed tablets usually are prepared by large-scale production methods, while molded tablets generally involve small-scale operations [1]
Properties of Tablets:
· Should be elegant product having its own identity while being free of defects such as chips, cracks, discoloration and contamination.
· Should have strength to withstand the rigors of shocks encountered in its production, packaging, shipping and dispensing.
· Should have the physical stability to maintain its physical attributes over time.
· Must be able to release the medicaments agent (S) in the body in a predictable and reproducible manner.
· Must have a suitable chemical stability over time so as not to allow alertation of the medicinal agent(S).
· Manufacturing of tablets requires number of unit operations like product includes weighing, milling, granulation, drying, blending, lubrication, compression and coating.
Natural binders:
Types of Binders:
A. Classification on the basis of their source:
1. Natural polymers: Starch, Pregelatinized starch, gelatin, acacia, Tragacanth and gums.
2. Synthetic polymer: PVC, HPMC, methyl cellulose, ethyl cellulose, PEG, Sugar: glucose, sucrose, sorbitol.
B. Classification on the basis of their application:
1. Solution binders:
They are dissolved in a solvent (for example water or alcohol can be used in wet granulation processes). Examples include gelatin, cellulose, cellulose derivatives, polyvinyl pyrrolidone, starch, sucrose and polyethylene glycol.
2. Dry binders:
They are added to the powder blend, either after a wet granulation step, or as part of a direct powder compression (DC) formula. Examples include cellulose, methyl cellulose, polyvinylpyrrolidone, and polyethylene glycol [2].
Natural polymers:
a) Advantages of Natural binder
1. Natural polysaccharides are widely used in the pharmaceutical and food industry as excipients and additives due to their low toxicity, biodegradable, availability and low cost.
2. They can also be used to modify the release of drug, thereby, influencing the absorption and subsequent bioavailability of the incorporated drug.
3. They act as ehicles which transport the incorporated drug to the sie of absorption and are expected to guarantee the stability of the incorporated drug, the precision and accuracy of the dosage, and also improve the organoleptic properties of the drugs where necessary in order to enhance patient adherence.
4. They can also be used to modify the release of drug and thereby influencing the absorption and bioavailability of the incorporated drugs.
5. Natural binders are widely used in the pharmaceutical and food industry as excipients and additives due to their low toxicity, biodegrable, availability and low cost [3].
b) Disadvantage of Polymer binders:
1. Polymer binders can lead to processing difficulties such as rapid over granulation. Over time they occasionally lead to tablet hardening and a decrease in dissolution performance.
2. When polymer binders are chosen, the addition of strong disintegtants such as super disintegrants is typically required but these are considerably expensive and have a negative effect on product stability as well as film coating appearance of the finished products [4].
3. Polymers binder can lead to processing difficulties such as rapid over granulation, tablet hardness increases & dissolution performance decrease.
4. When polymer binders are selected addition of strong disintegrates typically required but these are considerable expensive and have a negative effect on product stability.
Natural gum and mucilage as binder:
Most of the natural polymer (gum and mucilage) are formed by high molecular weight carbohydrates. They are biodegradable, biocompatible and non-hazardous polymers showing irregular physical-chemical properties and environmentally sustainable features. Carbohydrates represent the most abundant biological molecules, covering a large array of fundamental roles in living things: from the reserve and transport of energy, (starch and glycogen), to the development of structural components (cellulose in plants, chitin in animals), to the linking between intercellular walls (hemicellulose). The high molecular weight carbohydrates derived, are known as polysaccharides. They may be viewed as condensation polymers in which carbohydrates have been joined.
NATURAL BINDER NEEDS:
Binders are employed in pharmaceutical tablet formulations to provide adequate mechanical properties by promoting the bondig existing between the different compents of a powder mix in a formulation there by enhancing the strength tablet produced). various natural, synthetic and semi-synthetic substances such asstarches, cellulose and gums have been employed in pharmaceutical tablet formulation as binders.
Binders are agents employed to impart cohesiveness to the granules. This ensures the tablet remains intact after compression. The development of new excipients for potential use as binding agent in tablet formulations continues to be of interest. This is because different binding agents can be useful in achieving various tablet mechanical strength and drug release properties for different pharmaceutical purpose. Natural polysaccharides are widely used in the pharmaceutical and food industry as excipients and additives due to their low toxicity, biodegradable, availability and low cost. Natural binders like different starches, gums, mucilages dried fruits possess binding capacity as well as some other properties like disintegrant, filler, sustain release, and these natural polymers are much safer and economical than polymers like PVP. Different starches like rice, potato, maize, corn, wheat, tapioca starch and gums like ferula gummosa boiss, gum olibanum, beilschmiedia seed gum, okro gum, aegle marmelod gum, gum cordial, okra gum and cassia roxburghii seeds gum and plant fruit like date palm fruit and orange peel pectin shows good potency as a binding agent.
Gums are natural polysaccharides consisting of multiple sugar units linked together to form large molecule. They may be classified as natural, semi synthetic or modified and synthetic gums. These natural gums have found great use in the pharmaceutical industries due to their non-toxicity, ready availability and they are biodegradable. They have been explored as emulsifier, suspending agent, adhesives and binding agents. Most of the natural gums are safe for oral use in the food and pharmaceutical industries. However, the use of these gums could be associated with certain problems such as pH dependent solubility, uncontrollable swelling, change in viscosity on storage and possibly microbial contamination. Chemical modifications of these gums can be carried out to minimize these problems. Carboxymethylation of gums has been shown to increase the hydrophilicity thus, making them more soluble in aqueous systems. Grafting of acrylic acid on gums has been shown to modify the swelling characteristics and drug release properties of gums [5].
Excipients are additives used active pharmaceutical active ingredients convert in to pharmaceutical dosage form suitable for administration patients.
1. Binders are added to the tablet formulation to impart plasticity as well as increases interparticulate bonding strength in the tablet.
2. Granule and also increases the degree of consolidation or compactions while decreasing the brittle fracture tendency during tableting. The choice of a suitable binder for a tablet formulation requires extensive knowledge of the binder properties for enhancing the strength of the tablet and also interaction between various material constituting tablet.
3. Gums generally polysaccharides which are polymeric in nature of natural substance obtained from woody and non woody plant parts such as bark, seeds, sap, roots, rhizomes, fruit, leves and plant gums are widely used in formulation of pharmaceutical dosage forms. The major application of gum is a tablet, as binding agent.
This research work proposes to study utility of Aloe vera and Hibiscus rosa-sinensis mucilage as a binder in different tablet formulations and its evaluation.
MATERIAL AND METHOD:
EXTRACTION PROCSS:
A) Aloe vera:
Cutting the leaves from an Aloe vera plant. Cleaning of the said leaves by washing with distilled water. Drying of the collected leaves. Cut the upper portion of leaves with the help of sharp blade and physically removing the rind and collecting the mucilage under sterile conditions.
B) Hibiscus rosa-sinensis:
Leaves of Hibiscus were collected and carefully washed and dried under shade for 24 hrs and then further dried in an oven at 30-40o C. The dried leaves were subjected to grinding using an electric grinder. The powder was passed through sieve no.#22 then used for further evaluation.
Figure 1: Aloe vera
Hibiscus Rosa sinensis leaves
Figure 2: Hibiscus Rosa sinensis leaves
Extraction of Mucilage:
Powdered leaves of hibiscus were used for extraction of mucilage. The powdered leaves were placed in a 1000ml of beaker containing 500ml of distilled water and allowed it to boil for at least 3-4 hrs with continues stirring in water heat 60o C for sufficient release of mucilage in water. The concentrated solution was then filtrated through muslin cloth in order to separate marc from the filtrate and refrigerated for cooling (3-4o C) [6].
6.2. METHODOLOGY:
· Characterization of drug:
a. Organoleptic properties:
The sample of Paracetamol was analyzed for its color, odor and physical appearance.
b. Melting point:
Melting point Paracetamol was determined by open capillary method using thiele’s tube.
· Spectroscopic analysis
a. Determination of λ max
10 mg of pure Paracetamol was dissolved in 10ml of solvent methanol. Thus 100 μg/ml solutions were formed. 1 ml of stock solution was taken and suitably diluted with 10 ml of methanol solvent. Then solution was filtered and its UV spectrum was recorded in the wavelength range 247 nm.
b. Preparation of calibration curve of Paracetamol
From the stock solution of 100 μg/ml, 0.2 ml solution was taken and diluted upto 10 ml in methanol. Out of which, 0.4, 0.6, 0.8, 1 ml aliquots were taken and were diluted upto 10 ml in methanol solvent, and 2 μg/ml, 4 μg/ml, 6 μg/ml, 8 μg/ml, 10 μg/ml solutions were prepared respectively. The solutions were then filtered and analyzed spectrophotometrically at 247 nm using spectrophotometer and standard curve was plotted and values of slope, intercept and coefficient of correlation were calculated [7].
· EXPERIMENTAL WORK:
· Evaluation of Paracetamol tablet formulation:
1) Pre-compression parameters:
· Size determination
The size of the pellets was determined by sieve shaker method using sieves of different sizes. The sieves of sizes #20, #16 were placed on mechanical shaker and shaken for 15 minutes. The pellets retained on different sieves were collected and average pellets size was determined.
· Bulk density
Ten gram pellets were poured gradually through a funnel into a 50 ml graduated cylinder, tapped lightly on hard surface and the volume measured. Bulk density was calculated as the quotient of the weight and volume of pellets.
Db = M / Vb
Where, M- is the mass of powder.
Vb - is the bulk volume of the powder (ml).
· Tapped density
Ten gram pellets were poured gradually through a funnel into a 50 ml graduated cylinder tapped 50 times using USP density test apparatus. The packed bulk density was calculated as the quotient of the weight and volume sedimented.
Dt = M / Vt
Where, M- is the mass of powder (gm).
Vt - is the tapped volume of the powder.
· Hausner’s ratio
Hausner ratio is an indirect index of ease of powder flow. It is determined by the following formula:
Hausner’s ratio = Dt__
Db
Where, Dt is the tapped density.
Db is the bulk density.
· Angle of repose:
The repose angle was measured using a funnel with orifice diameter of 6 mm. Ten gram of pellets were placed in funnel and allowed to fall from 4 cm height onto a hard level surface. The repose angle was determined by the height and radius of the resulting pellets.
tan (θ) = h / r
(θ) = tan-1 (h / r)
Where, (θ) is the angle of repose
h is the height in (cm)
r is the radius in (cm). [8-9]
2) Post-compression parameters:
· Weight variation test:
The weight variation test was carried out in order to ensure the uniformity of weight in a batch. 20 tablets were selected randomly from each formulation and weighed individually. The US Pharmacopoeia allows a little variation in the weight of a tablet. The following percentage deviation in weight variation is allowed.
· Thickness:
Tablet thickness can be measured using a simple procedure. 5 tablets were taken and their thickness was measured using Vernier calliper.
· Friability test:
The friability of the tablet was measured using Roche friabilator. For tablet with an average weight 500mg or less take a sample of whole tablets corresponding to about 500mg and for tablets with an average weight of more than 500mg take sample of 10 whole tablets. Dedust and weigh accurately the required number of tablets. Place the tablets in the drum and rotate them 100 times. The tablets were dedust and weighed again. The percentage friability was measured by using the following formula:
% F = {(W0 – W1) /W0} x 100
Where, % F = friability in percentage
W0 = initial weight of tablets
W1 = final weight of tablets
· Hardness:
It is defined as the force applied across the diameter of the tablet in the order to break the tablet. The resistance of the tablet to chipping, abrasion or breakage under condition of storage transformation and handling before usage depends on its hardness. Hardness of the tablet of each formulation was determined using Monsanto Hardness tester.
· Wetting time (WT):
Five circular pieces of tissue paper (10 cm diameter) were placed in a Petri dish and10 ml water was added. A tablet was carefully placed on the surface of the tissue paper. The time required for the water to appear on the upper surface of the tablet was noted.
· Determination of drug content:
The drug content in each tablet formulation was determined by weighing crushed sample equivalent to 115 mg of Paracetamol and dissolved in 100 ml 0.1 N HCl. The sample solution was diluted with 6.8 pH phosphate buffer and sonicated for 20 min. The sample solution was centrifuged and filtered and absorbance measured at 247 nm using a UV Visible spectrophotometer.
· In vitro drug release studies:
2.5mg of Paracetamol was weighed and placed in 900 ml of dissolution media (0.1 M HCl) containing in USP dissolution apparatus II and stirred at a speed of 75 rpm at 370C. 5ml of aliquots were withdrawn at 5, 10, 15, 20, 25, 30 min and replaced by 5 ml of fresh dissolution media. The collected samples are measured at 247nm wavelength. The amount of drug released was calculated from the calibration curve of the same dissolution medium.
· Stability studies
The stability study of the formulated tablet was carried out under different conditions according to ICH guidelines. Tablets were stored in a stability chamber for stability studies. Accelerated Stability studies were carried out at 40C / 75% RH for the best formulations for 1 month. The characterized for the drug content and other parameters during the stability study period.
RESULTS AND DISCUSSION:
1. Authentication of the Drug:
a. Visual inspection:
Physical appearance of drug was examined for following organoleptic properties
· Color: white
· Odor: odorless
· Taste: tasteless
· State: fine powder.
b. Melting point:
Temperature was noted at which solid drug changes into liquid. It was found to be 169-172 0C.
2. Spectroscopic analysis:
a. Determination of λmax:
The standard solution of Paracetamol of concentration 100μg/ml showed maximum absorbance at the wavelength of 247.6 nm. Hence the λmax of Paracetamol was found to be 247nm.
Figure 3: Spectrum of Paracetamol in Methanol
b. Calibration curve of Paracetamol:
Calibration curve of Paracetamol in methanol. The Lambert’s- Beer’s law was found to be obeyed over the range of 2-14 µg /ml. The data for calibration curve of Paracetamol
Table 1: Data for Calibration curve of paracetamol in methanol
|
Sr No. |
Concentration(µg/ml) |
Absorbance |
|
1 |
2 |
0.1 |
|
2 |
4 |
0.15 |
|
3 |
6 |
0.121 |
|
4 |
8 |
0.25 |
|
5 |
10 |
0.356 |
Figure 4: Calibration Curve of Paracetamol
The details of calibration curve are as given below
Linear regression Equation is,
y= mx + c
Where, y =absorbance.
m = slope x = concentration and
c = intercept.
From the calibration curve equation obtained was
The value of slope (m) is 0.031.
The value of intercept (c) is 0.005.
The value of regression coefficient (R2) is 0.895.
· Compatibility study between drug and polymers
In FTIR spectra of Paracetamol, Aloe vera and Hibiscus rosa-sinensis. All the important peaks were found to be present, which confirmed the purity of sample. Table 2 shows peaks observed at different wave numbers and the functional group associated with these peaks for drug.
Table 2: Interpretation of IR spectra of Paracetamol
|
Peak No. |
Peak Position (cm-1) |
Functional Group |
|
1 |
3569.59 |
-OH |
|
2 |
2998.77 |
-CH Aromatic |
|
3 |
2883.08 |
-CH Aliphatic |
|
4 |
1648.06 |
-CONH |
Figure 5: FTIR spectra of Paracetamol
Figure 6: IR spectra of Aloe Vera
Table 3: Interpretation of IR spectra of Aloe Vera
|
Peak No. |
Peak Position (cm-1) |
Functional Group |
|
1 |
1043 |
C-N (Aliphatic amine) |
|
2 |
1369.21 |
O-H bond (carboxylic acid C-H bending |
|
3 |
1639.2 |
N-H (amine) |
|
4 |
2325.73 |
Overtone(weak) |
|
5 |
2360.44 |
C-N |
|
6 |
3477.03 |
N-H(amine) |
Figure 7: IR Spectra of Hibiscus rosa-sinensis
Table 4. Interpretation of IR spectra of Hibiscus rosa-sinensis
|
Peak No. |
Peak Position (cm-1) |
Functional Group |
|
1 |
1038.56 |
C-H blend out of plane |
|
2 |
1250.22 |
C-O bend ethers, aromatic |
|
3 |
1338.36 |
C-H rock |
|
4 |
1435.64 |
C-H bend |
|
5 |
1452.60 |
C-H bend |
|
6 |
1540.36 |
Amide |
|
7 |
1678.40 |
Alkyne |
|
8 |
1714.41 |
Ketone |
|
9 |
1735.64 |
Carboxylic acid |
|
|
|
|
Figure 7: IR Spectra of Mixture
Figure 8: IR Spectra of Mixture
INTERACTION:
If the drug and the polymer would interact, then the functional groups in the FTIR spectra would show band shifts and broadening compared to the spectra for the pure drug and polymer. The FTIR spectra obtained from the various polymers showed peaks which were a summation of the characteristic peaks obtained with the pure drug and pure carriers and spectra’s can be simply regarded as the superposition of those of paracetamol and Hibiscus rosa sinensis, Aloe Vera. This showed that here was no chemical interaction of the drug.
· Evaluation of formulated tablets
· Pre-compression Evaluation of tablet
As per procedure noted in the experimental part, the powder mixture was evaluated for angle of repose, bulk density, tapped density, Carr’s compressibility index, Hausner’s ratio and angle of repose. The results angle of repose and compressibility indicated that the flowability of blend is significantly good. The observations are shown in Table 5
Table 5: Physical Parameters of formulation blends of all batches
|
Sr No. |
Batch |
Bulk density(g/ml) |
Tapped density(g/ml) |
Angle of Repose (◦) |
Hausner’s ratio |
Carr’s index (%) |
|
1 |
F1 |
0.397±0.001 |
0.484±0.001 |
29.22±0.015 |
1.23±0.01 |
17.15±0.020 |
|
2 |
F2 |
0.355±0.001 |
0.457±0.001 |
28.21±0.01 |
1.24±0.02 |
14.41±0.015 |
|
3 |
F3 |
0.434±0.001 |
0.486±0.001 |
29.11±0.01 |
1.12±0.01 |
12.12±0.025 |
|
4 |
F4 |
0.046±0.001 |
0.464±0.001 |
29.24±0.015 |
1.16±0.01 |
17.31±0.015 |
|
5 |
F5 |
0.471±0.001 |
0.474±0.001 |
28.21±0.01 |
1.03±0.05 |
15.20±0.013 |
|
6 |
F6 |
0.299±0.002 |
0.397±0.001 |
27.90±0.068 |
1.5±0.03 |
15.43±0.029 |
Mean ± SD, n= 3
· Post compression evaluation of tablet:
All formulations were tested for physical parameters like hardness, thickness, weight variation, friability, thickness and disintegration time and were found to be within the pharmacopoeia limits. Disintegration time was graphically shown in Figure 9. The results of the tests were tabulated in Table6. All formulations show good compressibility. The formulated tablets were elegant and almost uniform thickness. Thickness of core tablets of paracetamol was in the range of 5 to 5.7 mm. The weight variation of tablets of all batches was in the range of 198.02±0.01mg to 199.61±0.01mg. The range of hardness was found to be 2.3±0.01 to 5.0±0.01kg/cm2. All the batches show less friability. In all formulation hardness test indicated good mechanical strength. In all the batches, friability was less than 1% which indicated good mechanical resistance and can withstand rigors of transportation and handling. The drug content of all the formulations was determined and was found to be within the permissible limit.
Table 6: Post-compression evaluation data of the prepared tablet formulations
|
Batch No. |
Weightvariation (mg) |
Thickness (mm) |
Friability (%) |
Hardness (kg/cm2) |
Disintegration Time (min) |
Drug Content (%) |
|
F1 |
198.02±0.01 |
5.2±0.1 |
0.67±0.01 |
2.3±0.01 |
18±0.01 |
56.41±0.5 |
|
F2 |
199.2±0.025 |
5.4±0.3 |
1.16±0.15 |
4.33±0.01 |
19±0.01 |
78.06±0.2 |
|
F3 |
196.57±1.18 |
5±0.3 |
0.51±0.01 |
4.33±0.01 |
20±0.01 |
84.13±0.2 |
|
F4 |
198.71±0.01 |
5.1±0.3 |
0.95±0.01 |
4.6±0.01 |
20±0.01 |
90.20±0.5 |
|
F5 |
199.61±0.01 |
5.7±0.3 |
0.86±0.01 |
5.0±0.01 |
21±0.01 |
93.49±0.1 |
|
F6 |
197.17±1.00 |
5.1±0.2 |
0.57±0.08 |
1.21±0.01 |
22±0.01 |
90.47±0.5 |
Mean ± SD, n= 3
Disintegration Time:
Disintegration time was observed to be in the range of 18 min to 22min. The results indicate that the disintegration time of all the batches of tablets is within 22 minute.
Figure 9: Disintegration behavior of the prepared tablets
· In-vitro dissolution studies:
The cumulative % of drug release of batch F1 prepared by direct compression showed 17.33% of drug released at 10 min, whereas F2 showed 17.28% drug release at 15min, F3 showed 13.83% drug release at 20min, F4 showed 63.56% drug release at 25min. F5 and F6 exhibited 93.49% and 90.47% drug release at 30min. Results of cumulative % drug release of all the batches are tabulated in Table 7 and graphically represented in Figure 10.
Figure 10: Graphical representation of Cumulative % drug release of tablets
Table 7: % Cumulative Drug Release
|
Sr no. |
Time |
% Cumulative Drug Release
|
|||||
|
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
||
|
1 |
10 |
17.33 |
16.14 |
10.85 |
12.49 |
56.40 |
50.12 |
|
2 |
15 |
27.30 |
17.28 |
11.10 |
13.62 |
64.69 |
73.55 |
|
3 |
20 |
44.74 |
61.92 |
13.83 |
49.21 |
73.30 |
80.25 |
|
4 |
25 |
49.42 |
64.69 |
60.37 |
63.56 |
78.10 |
86.20 |
|
5 |
30 |
56.41 |
78.06 |
84.13 |
90.20 |
93.49 |
90.47 |
· Stability study of optimized formulation:
During the stability studies no change in color was found in tablet formulation. From results, it was observed that there were no significant changes in hardness, appearance, drug content as well as percent drug release. Therefore, no evidence of degradation of drug was observed. All the values of evaluation after stability are tabulated in Table 8. The optimized formulation is evaluated for in-vitro drug release studies; the results indicated that there was no significant change in in-vitro drug release studies which is similar to the formulations under optimum conditions. The drug release from tablet formulations during stability study is shown in Table 9.
Table 8: Stability Studies of optimized batch of tablet
|
Sr no. |
Weightvariation (mg) |
Thickness (mm) |
Friability (%) |
Hardness(kg/cm2) |
DisintegrationTime (min) |
DrugContent (%) |
|
1 |
199.02±0.01 |
5.4±0.1 |
0.66±0.01 |
2.2±0.01 |
19±0.1 |
58.40±0.1 |
|
2 |
189.2±0.02 |
5.1±0.3 |
1.26±0.1 |
4.3±0.01 |
20±0.01 |
76.05±0.5 |
|
3 |
194.57±1.1 |
5.0±0.3 |
0.52±0.01 |
4.30±0.01 |
21±0.01 |
82.13±0.2 |
|
4 |
197.71±0.01 |
5.3±0.3 |
0.85±0.01 |
4.5±0.01 |
22±0.1 |
91.20±0.5 |
|
5 |
192.61±0.01 |
5.9±0.3 |
0.87±0.01 |
5.0±0.01 |
22±0.01 |
94.49±0.2 |
|
6 |
195.17±1.00 |
5.1±0.2 |
0.55±0.08 |
1.20±0.01 |
21±0.1 |
90.47±0.5 |
Mean ± SD, n= 3
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Received on 17.12.2019 Modified on 16.01.2020
Accepted on 10.02.2020 ©Asian Pharma Press All Right Reserved
Asian J. Pharm. Tech. 2020; 10(1):29-37.
DOI: 10.5958/2231-5713.2020.00007.0