RESEARCH ARTICLE

Formulate and Evaluation of Oral Herbal Tablet of Kalanchoe pinnata and Rotula aquatic
Gilhotra Umesh Kumar1*, Christina A.J.M.2
Abstracts: In the present study an attempt has been made to prepare oral herbal tablet of Kalanchoe pinnata and Rotula aquatica. The tablets were prepared with three super disintegrate i. e. crospovidone, sodium starch glycolate, cros-linled sodium carmellose, binder i.e. poly vinyl pyrolidine. The blend was examined for angle of repose, bulk density, tapped density, compressibility index and hausners ratio. The tablets were evaluated for hardness, weight variation, thickness, friability and were found satisfactory. The disintegration time was also tested. Such evaluation has unique position in development of oral herbal tablet formulation of Kalanchoe pinnata and Rotula aquatica. Key Words: Formulation, Tablet, Kalanchoe pinnata, Rotula aquatica INTRODUCTION Herbal Medicine is the oldest form of healthcare known to mankind. Herbs had been used by all cultures throughout history. It was an integral part of the development of modern civilization. Primitive man observed and appreciated the great diversity of plants available to him. The plants provided food, clothing, shelter and medicine. Much of the medicinal use of plants seems to have been developed through observations of wild animals and by trial and error. As time went on, each tribe added the medicinal power of herbs in their area to its knowledge base. They methodically collected information on herbs and developed well-defined herbal pharmacopoeias. Indeed, well into the 20th century much of the pharmacopoeia of scientific medicine was derived from the herbal lore of native people. Many drugs commonly used today are of herbal origin. Indeed, about 25% of the prescription drugs dispensed in the United States contain at least one active ingredient derived from plant material. Some are made from plant extracts; others are synthesized to mimic a natural plant compound. Herbal medicinal products are defined as any medicinal product, exclusively containing one or more active substances. WHO report 80% of the world population relies on the drug from natural origin.[1] The oral route of drug administration is the most important method of administrating drugs for systemic effects. Except in few cases, parenteral route is not routinely used for self administration of medications. The topical route of administration is limited in its ability to allow effective drug absorption for systemic drug action. It is probable that most of drugs used to produce systemic effects are
1Goenka

administered by the oral route. Ayurvedic herbal formulations were also administered preferentially by oral route.[2] Solid oral dosage forms represent the preferred class of product for orally administered drugs. Advantage beings unit dosage forms easy to handle and transport, convenient and safe. Liquid forms of drugs have certain limitation.[3] Designing of oral herbal formulations is till date a challenge in modern pharmaceutics. There are number of medicinal herbs in traditional system of medicine which are time tested, useful for the number of ailment. There are many medicinal plants mentioned in ayurvedic Texts/Nighantus from jwaraghna group like Bergenia ligulata, Carateva nurvala, Costus spiralis, Tribulus terrestris, Dolichos biflorus, Musa paradisiacal etc.,[4] which have application in diuretic and in renal lithiasis. In present study the two ayurvedic medicinal plants parts such as Kalanchoe pinnata leaves and Rotula aquatica roots were selected for designing the possible modern formulations. MATERIALS AND METHODS Kalanchoe pinnata and Rotula aquatica roots were collected from the medicinal farm Hanumangarh, India. The plant was then authenticated by the Dr. G. C. Abraham. The American College, Madurai,Tamilnadu, India. poly vinyl pyrolidine, Microcrystalline Cellulose, Cross Povidone, Sodium Starch Glycolate, Cross-linked Sodium Carmellose and Aerosil were purchased from Loba chemicals Ltd. Mumbai. All other chemicals used were of analytical grade. Extraction Process The preliminary Phytochemical screening of the plant involves extraction of the plant material and identification of the plant active constituents.[5] Preparation of Extracts The leaves of Kalanchoe pinnata and rhizome of Rotula aquatica were collected and identified. Both plants is cut down into small

pieces, shade dried and powdered to get moderately coarse powder, which is sieved under mesh size 40. About 500g of the dry powder was extracted with petroleum ether, chloroform, benzene and ethanol at 60-70oc by continuous hot percolation using soxhlet apparatus. The extraction was carried out with 2 L for 72 hours. The petroleum ether, chloroform, benzene and ethanol extract was filtered and concentrated to a dry mass by using vacuum distillation. The petroleum ether extract was obtained as dark green residue. The chloroform and benzene extract was obtained as dark green brown residue. The ethanol extract was obtained as dark brown residue. The yield was 20g of Kalanchoe pinnata and 22gof Rotula aquatica. Preparation of Mixed Blend of Drug and Excipients All the ingredients were passed through mesh no. 60. Required quantity of each ingredient was taken for each specified formulation (depicted in the table 1) and all the ingredients were subjected to a required degree of fineness. The powder blend was evaluated for flow properties as follows. Angle of Repose Angle of repose was determined using funnel method.[6] The blend was poured through a funnel that can be raised vertically until a maximum cone height (h) was obtained. Radius of the heap (r) was measured and the angle of repose (q) was calculated using the formula. = Tan-1 (h/r) (1)

Bulk Density Apparent bulk density (b) was determined by pouring the blend into a graduated cylinder. The bulk volume (V .) and weight of the powder (M) was determined. The bulk density was calculated using the formulaBulk Density (b) = M/ V. (2)

Tapped Density The measuring cylinder containing a known mass of blend was tapped for a fixed time. The minimum volume (VT ) occupied in the cylinder and weight (M) of the blend was determined. The tapped density (t) was calculated using the following formulaTapped Density (t) = M/ VT (3)

College of Pharmacy, Lachhmangarh, Rajasthan, India E-mail: gilhotrauk@gmail.com *For correspondence

2K.

M. College of Pharmacy, Madurai, Tamilnadu, India

Compressibility Index The simplest way for measurement of free flow of powder is compressibility, a indication of the ease with which a material can be

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Table 1: Formulae for Preparing Tablet dosage Forms Sr. No. 1. 2. 3. 4. 5. 6. 7. 8. Ingredients Kalanchoe pinnata Rotula aquatica Microcrystalline Cellulose Cross Povidone Sodium Starch Glycolate Cross-linked Sodium Carmellose Poly Vinyl Pyrolidine Aerosil T1 250 mg 250mg 130 20 20 15 10 5 Formulations T2 250mg 250mg 120 15 20 20 20 5 T3 250 mg 250mg 100 mg 25 mg 25 mg 25 mg 20 mg 5

Table 2: Evaluation of Powder Blend Batch Angle of Repose Carrs Index (%) T1 28.79 17 T2 30.96 16.98 T3 27.54 15.07 Table 3: Evaluation of Tablets Batch Hardness (Kg/cm2 ) T1 4.2 T2 4.1 T3 4.4

Bulk Density(gm/ml) 0.42 0.44 0.41

Tapped Density(gm/ml) 0.51 0.53 0.54

Hausners Ratio 1.13 1.20 1.31

Thickness (mm2) 3.6 3.6 3.5

%Weight Variation 2.48 2.51 2.21

% Friability 0.81 0.93 0.72

Disintegration Time(min) 15 14 13

induced to flow is given by compressibility index (I) which is calculated as follows, I= V0-Vt/Vbx (4)

Where V0 is the bulk volume and Vt is tapped volume. The value below 15% indicates a powder with usually give rise to good flow characteristics; whereas above 25% indicate poor flowability. Hausner Ratio: Hausner ratio is an indirect index of ease of powder flow. It is calculated by the following formula Hausner ratio =t/d Where t is tapped density and d is bulk density, Lower hausner ratio (<1.25) indicates better flow properties than higher ones (>1.25). Formulation of Tablets The ingredients depicted in table I (except aerosil) were mixed homogenously and required degree of fineness was attained. Finally aerosol was added and mixed. The mixed blend of drug and exciepients was compressed using a single punch tablet punching machine to produce tablets, weighing 700 mg each with a diameter 8 mm. Drug Excipient Compatibility Test [9] Compatibility of the drug with excipients was determined by FT-IR spectral analysis, this study was carried to detect any changes on chemical constitution of the drug after combining it with the excipients. The samples were taken for FT-IR study. IR spectra of drug in KBr pellets at moderate scanning speed between 4000-400 cm-1 was carried out using

FTIR. The peak values (wave number) and the possibility of functional group are shown in spectra which compare with standard value. The comparison of these results with chemical structure shows that the sample was pure aqueous extract Evaluation of Tablets The Three forms of Tablet (T1, T2, and T3) were evaluated for general appearance, friability test, hardness test, weight variation test and disintegration test.[7,8] RESULT AND DISCUSSION The primary objective of this work was to develop oral herbal dosage form of Kalanchoe pinnata and Rotula aquatica. The development of such formulations will mark an important advancement in the area of phytopharmaceuticals. The present investigation examines design & development of solid oral herbal dosage form. The solid oral herbal dosage form, tablets were prepared using poly vinyl pyrolidine as binder, three super disintegrate in varying concentration such as crospovidone, sodium starch glycoate, cross-linked sodium carmellose, and microcrystalline cellulose as filler and aerosil as glidants. For each formulation, blend of drug and excipients were prepared and evaluated for various parameters as explained earlier. The powder blend was compressed using direct compression technique. Bulk density was found in the range of 0.410.44g/cm3 and the tapped density was found in the range 0.51-0.54 g/cm3. Using these twodensity data Hausners ratio and compressibility index was calculated. The powder blends of all the formulations had Hausners ratio of 1.2 or less indicating good

flowability.[10] The compressibility index was found between 15.07 - 17 and the compressibility- flowability correlation data[11] indicated a fairly flowability of the powder blend. The good flowability of the powder blend was also evidenced with angle of repose (range of 24-290) which is below400 indicating good flowability. Tablet was prepared using direct compression technique. [12] Since the powder material was free flowing, tablets were obtained of uniform weight variation as per pharmacopoeial specifications. The weight variation was found between 2.21 mm 2.51mm and the hardness of the tablets between 4.1-4.4kg/cm2. Friability of the tablets was found below 1% indicating a good mechanical resistance of tablets. The disintegration time of the tablets was found between 11-13 minutes. All the parameters were found well within the specified limit for uncoated tablets. The prepared tablets were brown colour with smooth surface having acceptable elegance. T3 form of tablets was good quality with regard to hardness, friability & weight variation. CONCLUSION Oral herbal dosage form of Kalanchoe pinnata and Rotula aquatica in combination of tablets showed good elegance & palatability. Tablet dosage form is of good quality with regards to characteristics like hardness, friability, weight variation and disintegration. Thus it can be concluded that oral dosage form of tablet could be suitable dosage form for Kalanchoe pinnata and Rotula aquatica.

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Pharmaceutical Sciences review and research 2010; 3(1): 101-110 10. Tang L, Khan SU, Muhammad NA. Evaluation and selection of bio relevant dissolution media for a poorly water soluble new chemical entity. Pharmaceutical Development Technology 2001; 6(4): 531-540 11. Lachman L, Liberman HA, Kanj JZ. The theory and practice of industrial pharmacy 3rd ed. Mumbai: Varghese Publishing House; 1987. P. 171-196. 12. Madosiya MK. Lala II, Prajapati BG, Patel VM, Shah DA. Design and characterization of fast disintegrating tablets of piroxicam. International Journal of Pharm. Tech. Research. 2009; 1(2):353-357.

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