Preparation of disintegration tablet using Cucurbita maxima pulp powder as disintegration

GPAT courses

Pharma courses

pharma courses

pharma courses

Lactose: Lactose is a carbohydrate, and as such a disaccharide. One Molecule of lactose consists of one molecule each of two other carbohydrates, i.e. galactose and glucose. These galactose and glucose moieties, as they are called, are linked together by means of what is known as a beta-(1,4) glucosidic linkage. The molecular structure of lactose is depicted below.

The official chemical name of lactose, as frequently encountered in regulatory documents such as the Pharmacopoeia is:
4-O-β-D-galactopyranosyl, D-glucopyranose.

A number of natural or partially modified polymers was screened for mucoadhesive properties by routinely measuring the force of detachment for swollen polymer films from pig intestinal mucosa in a saline medium. Suprisingly, hydroxypropyl- and carboxymethylcellulose showed almost no mucoadhesion, whereas the cationic polymer chitosan was fairly mucoadhesive in comparison to Polycarbophil as a reference substance. It is suggested that a strict difference be made between mucoadhesion of dry polymers on a wet tissue in air, and mucoadhesion of a swollen hydrogel in the presence of a third liquid phase. Cationic polymers should be further investigated with respect to possibly improved mucoadhesive properties in a neutral or slightly alkaline environment.Lactose is very stable from a chemical point of view. Except for some special cases, it has no tendency to react with the active ingredient or other components of a formulation. Some remarks on the chemical properties of lactose are useful, however
The low hygroscopicity of lactose supports its virtual chemical inertness. Most chemical reactions of lactose occur noticeably only in aqueous environments. Because lactose has no tendency to attract moisture, water in dry lactose preparations is normally not present in amounts sufficient for chemical reactions to proceed at a noticeable speed. The water of crystallisation is bound so tightly in the crystal lattice of the lactose that it is chemically inert.                    

α / β-isomer: In milk, lactose is present in two isomeric forms called α- and β-lactose. The molecular structures of α- and β-lactose differ in the orientation of a hydrogen and a hydroxyl group on carbon atom no. 1 in the glucose moiety. Both forms change into one another continuously. This phenomenon is called mutarotation. The velocity of mutarotation is determined by factors such as temperature, concentration, and pH (acidity) of the solution.
Lactose solutions seek a state of equilibrium between α and β form. At room temperature, the equilibrium results in a ratio of about 40% α-lactose and 60% β-lactose. The fact that two forms of lactose exist that differs in molecular structure has profound effects on various properties of lactose, such as its solid state properties, crystal morphology and solubility. [33-35]

 List of Materials Used



Polyvinyl Pyrrolidone K30

Central Drug House, New Delhi

Magnesium stearate

Central Drug House, New Delhi


Central Drug House, New Delhi


Central Drug House, New Delhi

Sodium hydroxide

Central Drug House, New Delhi

Hydrochloric acid

Central Drug House, New Delhi

List of Equipments used


Model, Manufacturer & Country

UV-Visible Spectrophotometer

Pharmaspec-1700, Shimadzu, Japan

FTIR- Spectrophotometer

8400s, Shimadzu, Japan

Dissolution Apparatus

Lab India Disso Test Appartus, India

Magnetic Starrier

5MLH DX, Remi, India

pH meter

SE946-P, Systronics

Electric Oven

Ambassadar® Laboratory Electric Oven, New Delhi, India

Friability Test Apparatus

Electrolab- EF-2 Friability (USP)

Hardness Tester

Model:EL=500N, Electrolab

Table: Formulations of matrix tablet: [36]



Batch 1

Batch 2

Batch 3













Polyvinyl Pyrrolidone









Bulk density: Apparent bulk density (g/ml) was determined by placing pre-sieved bulk powder blend into a graduated cylinder via a large cylinder and measuring the volume and weight of powder blend.

Bulk density =weight of powder blend / volume of powder blend

Tapped density: It was determined by placing a graduated cylinder, containing a known mass of powder on mechanical tapping apparatus, which was operated for fixed number of taps (around 50). Using the weight of powder in a cylinder and its tapped volume, the tapped density was computed.

Tapped density =weight of powder blend/ tapped volume of powder blend

Carr’s index: It is an important parameter to study compressibility behavior of powder blend. Carr’s index was calculated, from the results of bulk density and tapped density.

Carr’s index = (bulk density-tapped density)/ tapped density

Bulkiness: It is reciprocal of bulk density, and calculated as follows-

Bulkiness= 1/bulk density

Angle of repose: For the measurement of angle of repose, a glass funnel was taken with its tip at a given height (H), above a piece of graph paper placed on a horizontal surface. Powder was poured through the funnel until the apex of the conical pile touched the tip of the funnel. The angle of repose was calculated with the formula; tan θ= H/R, where θ is the angle of repose and R is the radius of the conical pile.

Swelling index: The swelling index is defined as the volume (in milliliters) taken up by the swelling of 1 g of powder material under specified conditions. 1 gm of the pulp powder was introduced into a 25 ml glass-stoppered measuring cylinder. Twenty five milliliters of water was added and mixture was shaken thoroughly for 10 min. It was then allowed to stand for 24 h at room temperature. Then the volume occupied by the pulp powder was noted.

 Weight variation: All prepared matrix tablets were evaluated for weight variation as per USP XXIV monograph. Twenty tablets of each batch were used to evaluate weight variation among tablets and standarddeviation was calculated.

 Friability: Tablets of all batches were used to evaluate friability as per USP XXIV monograph. Friability testing was done by Roche friabilator with triplicate readings.

Hardness: Hardness of all batches was determined using Digital Force Gauge (Model:EL=500, Electrolab). The test was carried out in triplicate for all batches as per USP XXIV monograph for uncoated tablets.

 Thickness: Thickness was measured by vernier caliper as per USP XXIV monograph. The readings were carried out in triplicate and average value was noted.

Drug content: The tablets were powdered, and 50 mg equivalent weight of Diclofenac Sodium in tablet powder was accurately weighted and transferred into a 100 ml volumetric flask. Initially, 10 ml of phosphate buffer (pH6.6) was added and shaken for 10 min. then, the volume was made up to 100 ml with buffer. Subsequently, the solution in volumetric flask was filtered and 1 ml of the filtrate was diluted and analyzed at 276 nm using ultraviolet/visible variable wavelength spectrophotometer at 276 nm (Shimadzu UV-2450, Japan). The drug content of the each sample was estimated from their standard curve.

In vitro dissolution study: Dissolution test was performed at 37°C using the paddle method at 100 rpm with    900phosphatebuffer (pH6.6) as a dissolutionIndia Disso 2000, India) was used. At predetermined intervals, 5 ml of the medium was sampled and filtered. The filtrate was analyzed by ultraviolet/visible variable wavelength spectrophotometer at 276 nm.

 Charcterization parameters of cucurbita maxima pulp powder

Beta vulgarispulp powder was characterized as a pharmaceutical excipient in terms of micromeritic properties and flow behavior. Bulk density, tapped density, bulkiness and angle of repose all are found to be good to use this plant based material as a pharmaceutical excipient. Bulk density, tapped density, cars index, hausner’s ratio porosity  and flow behavior (angle of repose) were found to be  0.51to.052,  0.52 to 0.053 ,0.84 to 0.045, 1.05 to 0.076,0.052 t0 0.02, 38.65 to 0.089 respectively .his pulp powder can be act as a good candidate for pharmaceutical preparations . Relative study of physical parameters of tablets of each batch of Beta vulgaris pulp powder reveals that the tablets compressed using pulp powder as disintegrant are quite harder, so can be easily handled. The variation in the hardness, weight variation, friability and thickness values of all the fabricated tablets were found to be 21.8 to 0.06, 211 to 0.03,0.62 to 0.82%,2.46 to 0.06 respectively in reference to average values for each parameter, were found within the official limits. Friability of tablets ranged from 0.62 to 0.82%, easily predict the fact that tablets were less friable and so provide ease of handling. Less weight variation and uniform drug content easily elicit the fact that this process of tablet formulation is reproducible and so easily adopted at industrial level. Findings of the results showed that as the concentration of pulp powder increases wetting time of tablets decreases in same proportion and so disintegrating time also go down in same manner.

Bulk density



Tapped density





Hausner’s ratio





Angle of repose (º)















Evaluation parameters of tablet containing Diclofenac sodium as a model












Friability (%)







Thickness (mm)







Diameter (mm)







Disintegration (min)







Weight Variation (mg)


± 0.067


± 0.059



The comparative study of various parameters clearly states the fact that the naturally obtained Beta vulgaris pulp powder stands as a good candidate to act as disintegrant and it is possible to design promising Fast disintegrating tablet using this polymer. On the basis of results obtained it can be concluded that this polymer having good micromeritic properties and flow behavior and so may act as a pharmaceutical excipient.

1 J.C. Rodriguez-Cabello, J. Reguera, A. Girotti, M. Alonso and A.M. Testera, Developing functionality in elastin-like polymers by increasing their molecular complexity: the power of the genetic engineering approach, Prog. Polym. Sci. 30 (2005), pp. 1119–1145.
2.X.D. Guo, Q.X. Zheng, J.Y. Du, S.H. Yang, H. Wang, Z.W. Shao and E.J. Sun, Molecular tissue engineering: concepts, status and challenge, J. Wuhan Univ. Technol. 17 (2002), pp. 30–34.
3. H. Uludag, P. De Vos and P.A. Tresco, Technology of mammalian cell encapsulation, Adv. Drug Deliv. Rev. 42 (2000), pp. 29–64.
4. A. Chilkoti, T. Christensen and J.A. MacKay, Stimulus responsive elastin biopolymers: applications in medicine and biotechnology, Curr. Opin. Chem. Biol. 10 (2006), pp. 652–657.
5. A. Patel, B. Fine, M. Sandig and K. Mequanint, Elastin biosynthesis: the missing link in tissue-engineered blood vessels, Cardiovasc. Res. 71 (2006), pp. 40–49.
6. B. Chevallay and D. Herbage, Collagen-based biomaterials as 3D scaffolds for cell cultures: application for tissue engineering and gene therapy, Med. Biol. Eng. Comput. 38 (2000), pp. 211–218.
7. D.R. Eyre, Collagen: molecular diversity in the body's protein scaffold, Science 207 (1980), pp. 1315–1322.
8. P.D. Kemp, Tissue engineering and cell-populated collagen matrices, Methods Mol. Biol. 139 (2000), pp. 287–293.
9. C.H. Lee, A. Singla and Y. Lee, Biomedical applications of collagen, Int. J. Pharmacogn. 221 (2001), pp. 1–22
10. C. Wong Po Foo and D.L. Kaplan, Genetic engineering of fibrous proteins: spider dragline silk and collagen, Adv. Drug Deliv. Rev. 54 (2002), pp. 1131–1143.
11. Y. Chunlin, P.J. Hillas, J.A. Buez, M. Nokelainen, J. Balan, J. Tang, R. Spiro and J.W. Polarek, The application of recombinant human collagen in tissue engineering, BioDrugs 18 (2004), pp. 103–119.
12.. K. Nishinari and R. Takahashi, Interaction in polysaccharide solutions and gels, Curr. Opin. Colloid Interface Sci. 8 (2003), pp. 396–400.
13. M.G. Cascone, N. Barbani, C. Cristallini, P. Giusti, G. Ciardelli and L. Lazzeri, Bioartificial polymeric materials based on polysaccharides, J. Biomater. Sci., Polym. Ed. 12 (2001), pp. 267–281.
14. J. Venugopal and S. Ramakrishna, Applications of polymer nanofibers in biomedicine and biotechnology, Appl. Biochem. Biotechnol. 125 (2)
15. K.I. Kivirikko, Collagen biosynthesis: a mini-review cluster, Matrix Biol. 16 (1998), pp. 35-37.
16. R. Berisio, L. Vitagliano, L. Mazzarella and A. Zagari, Recent progress on collagen triple helix structure, stability and assembly, Prot. Pept. Lett. 9 (2002), pp. 107–116.
17. B. Brodsky and J.A. Ramshaw, The collagen triple-helix structure, Matrix Biol. 15 (1997), pp. 545–554.
 18. Y. Tabata and Y. Ikada, Protein release from gelatin matrices, Adv. Drug Deliv. Rev. 31 (1998), pp. 287–301.
19. S. Young, M. Wong, Y. Tabata and A.G. Mikos, Gelatin as a delivery vehicle for the controlled release of bioactive molecules, J. Control. Release 109 (2005), pp. 256–274.
20. K.B. Djagny, Z. Wang and S. Xu, Gelatin: a valuable protein for food and pharmaceutical
 industries: review, Crit. Rev. Food Sci. Nutr. 41 (2001), pp. 481–492.
21. G.H. Altman, F. Diaz, C. Jakuba, T. Calabro, R.L. Horan, J. Chen, H. Lu, J. Richmond and D.L. Kaplan, Silk-based biomaterials, Biomaterials 24 (2003), pp. 401–416.
22. M.B. Hinman, J.A. Jones and R.V. Lewis, Synthetic spider silk: a modular fiber, Trends Biotech. 18 (2000), pp. 374–379.
23. Y. Tamada, New process to form a silk fibroin porous3-D structure, Biomacromolecules 6 (2005), pp. 3100–3106.
24. E. Khor and L.Y. Lim Implantabl applications of chitin and chitosan, Biomaterials 24 (2003), pp. 2339–2349.
25. W.R. Morrison and J. Karkalas, Starch. In: P.M. Dey, Editor, Methods in Plant Biochemistry: Carbohydrates vol. 2, Academic Press Limited, London (1990), pp. 323–352
26. K. Poutanen and P. Forssell, Modification of starch properties with plasticizers, Trends Polym. Sci. 4 (1996), pp. 128–132.
27. P.A. Dell and W.G. Kohlman, Effects of water-content on the properties of starch poly(ethylene vinyl alcohol) blends, J. Appl. Polym. Sci. 52 (1994), pp. 353–363.
28. C. Bastioli, A. Cerutti, I. Guanella, G.C. Romano and M. Tosin, Physical state and biodegradation behavior of starch–polycaprolactone systems, J. Environ. Polym. Degrad. 3 (1995), pp. 81–95.
29. M. George and T.E. Abraham, Polyionic hydrocolloids for the intestinal delivery of protein drugs: alginate and chitosan — a review, J. Control. Release 114 (2006), pp. 1–14.
30. M.M. Stevens, H.F. Qanadilo, R. Langer and V. Prasad Shastri, A rapid-curing alginate gel system: utility in periosteum-derived cartilage tissue engineering, Biomaterials 25 (2004), pp. 887–894.
31. I.L. Jung, K.H. Phyo, K.C. Kim, H.K. Park and I.G. Kim, Spontaneous liberation of intracellular polyhydroxybutyrate granules in Escherichia coli, Res. Microbiol. 156 (2005), pp. 865-870
32. Sujja-areevath J.Munday D L ,Cox P J,KhanKa,Release Characterstics of Diclofenac  Sodium for Encapsulated
33. Shangraw, R. F: Compressed Tablets by Direct Compression Granulation Pharmaceutical Dosage Forms: Tablets, Vol-1, 2nd   ed. Marcel Dekker, USA, 1989. p.195-246.
34.Shangraw , R. F: Direct Compression Tableting: Encyclopedia of Pharmaceutical Technology, Vo-4, 2nd ed. Marcel Dekker, USA, 1988. p.85-160.
35. Reimerdes, D: The Near Future of Tablet Excipients, Manuf. Chem., 1993; 64:14-15.
36. Abraham B ,Alpsien M , Bake B Lawson A, Sjogren J.In vitro & in vivo erosion of 2 different Hydrophilic Gel matrix tablet, Eur J pharma Biopharm 1998,46,69-75
37. Malviya Rishabh Pranati ,Bbansal Mayank, Sharma P.K preparation &Evaluation of Disintegrating properties of cucurbita Pulp powder, Integration Journal of Pharmaceutical Science.(accepted manuscript (JP-09,119)2010.



Subscribe to Pharmatutor Alerts by Email