Vati/gutika:: Preparation and standardization

This presentation intends to introduce about ayurvedic tablets known as gutikas or vatis. The content is suitable for undergraduate pharmacy students and high school science learners. It focusses on preparation and standardization. This topic is part of herbal drug technology of B.Pharmacy PCI curriculum.

1. VATI/GUTIKA : A SOLID DOSAGE AYURVEDIC FORMULATION- PREPARATION AND STANDARDIZATION Dr P.J.Prasuna Sundari M.Pharm., Ph.D [email protected] 1

2. INTRODUCTION Vati ( tablet dosage form) is an important drug delivery system in Ayurveda. Acharya Sharangadhar in 13th century AD was the 1st person who explained in detail about Bhaishajya kalpana (bhaishajya means medicine; Kalpana means dosage forms)in Sharangadhara Samhita. He explained various kalpanas and in one of these chapters he explained about vati. Vati kalpana is a pharmaceutical procedure in which the powder of raw drugs (herbal or herbo-minerals) triturated together with certain juices, infusions, decoctions or even honey and then are prepared in the form of pills or tablets. 2

3. S.No Dosage form shape Example with use 1 Gutika (pill) circular shape dosage shape of flat form eladi gutika – used in various kidney ailments. 2. Vati circular mass, similar to tablet. sarpagandha vati - hypertension, insomnia, mental disorders etc. .3 Varti long oval shape form,(yava shape- thick in the middle with tapering ends). This form is meant for administration into body cavities like anorectum, vagina, urethra and eye. chandrodaya varti is a collyrium, to treat early stages of cataract, growth on the eyes etc. 4.. Vataka big circular mass form manasamitra vataka – psychosomatic illness. 5. Modaka is also a round shaped pill, but its size is bigger and its weight around 20 g, 50 g. balabilwadi modaka – complementary ayurvedic food 6. Pinda or Pindi Aushadhi churna is mixed with sugar and moulded like Pinda(circular mass) then it is called as Pinda or Pindi. The size of that of a ‘single bolus of food. Rasona pinda – asthma, arthritis. 7. Guda Similar to Pinda shape, but is of peanut size Types of vatis based on shape/size 3

4. Methods can be divided into 2 categories: 1 . With the aid of heat 2. Without the aid of heat 1. With the help of heat – Desired quantity of base drugs like jaggery, sugar, guggul are taken in a clean wide mouthed stainless steel vessel of suitable size. Required quantity of water is added and the contents are heated over fire with frequent stirring. Once the syrup is formed , the fine powder of drugs is added in small quantities and stirred well till the desirable consistency is obtained. Then the mass is rolled into pills of desired size and shape. The prepared pills are later dried in shade and stored in airtight containers. General methods of preparation 4

5. 2. Without the aid of heat - a) Desired quantity of base drugs like guggul and jaggery are pounded well in mortar and pestle. Fine powder of drugs are then added in small quantities. When the drug mass attains the required consistency, it is then rolled into pills of desired size and shape. They are later dried in shade and stored in airtight containers. b) Fine powder of medicinal drugs is taken in khalva yantra/mortar and pestle. Specified liquids like water, cow’s milk, swarasa, kwatha, honey etc are added in required quantity. The mixture is triturated until drug mass attains the required consistency. Later the pills of desired size are rolled, dried in shade and stored in airtight containers. 5

6. Sequence of including various components in the formula Drugs of plant origin are dried and made into fine powders separately. Minerals are made into Bhasma or Sindura, unless otherwise mentioned. In case the formula contains mercury and sulphur, then Kajjali is made first and other drugs are added with it one by one according to the formula. These are put into a Khalva and ground to a soft paste with the prescribed fluids. When more than one liquid is mentioned for grinding they are used in succession. When the mass is properly ground and is in a condition to be made into pills, sugandha dravyas are added and ground again. The criteria to determine the final stage of the formulation before making pills is that, it should not stick to the fingers when rolled in between two fingers. Pills may be dried in the shade. In case where sugar or Jaggery is mentioned, syrup should be made on mild fire. The medicinal powders are added to that syrup and briskly mixed. When still warm, vatakas should be rolled and dried in shade. 6

7. Ratio of essential components in the preparation of vati The ratio in relation with fine powder of medicinal drugs is as follows. Crystallized rock sugar – 4 times jaggery – 2 times Guggul and honey – equal proportions Water/ or any other liquid – 2 times more than that of Churna used for Vati. 7

8.   Vati matra (dosage): karsha (12gms) is the general dosage of the vati or as directed by the physician. Vati is administered along with water, honey, milk or any other suitable liquid preparation. Shelf life : pills prepared from herbal drugs – 2 years pills of mineral drugs - indefinite time period; no expiry date. Storage conditions: Vati or Ayurvedic tablets should be stored so as not lose their original colour, smell, taste and form. They should be preserved in airtight containers. When sugar, jaggery or salt is an ingredient, the Vati or Ayurvedic tablets should be kept away from moisture. 8

9. Merits of vati / gutikas Patient acceptance : Bitter taste and irritating odour of the drugs can be masked. Pills can be carried by the user without inconvenience, thereby permitting regular dosage, a condition difficult to achieve with liquid medicines. They can be swallowed easily. 2. Stability: Drugs in the solid form are usually more chemically stable. Shelf life is enhanced compared to many other dosage forms. Where there is the possibility of a gradual loss of potency, the date of manufacture should be mentioned on the container. It helps retain the volatile principles in the formulation. 9

10. : 3) Accuracy of dosage: The drugs and excipients are uniformly mixed in the trituration process. This helps comply better with content uniformity and assay. The patient thus receives the intended dose ( difficult with liquid medicines as doses are measured in domestic spoons of varying capacities) . Fixation of dosage is easy as it is a unit dosage form. 4) Economy: Pills are made by mass production method on machines of high efficiency and output. Easy to pack and dispense . This dosage form suits better for large scale production. 10

11. 1. It should contain the stated dose within permitted limits. 2. It should be sufficiently hard to withstand reasonable handling from the time of manufacture until they reach the consumer. 3. It should be a suitable size for easy administration. 4.It should be free from physical imperfections and foreign matter. 5. It should disintegrate readily. 6. It is preferable to use micro fine powder for the preparation of Vati Characteristics of Good quality pills/Tablets 11

12. Standardization of vati formulations - Analytical parameters for analysis A . Organoleptic parameters: 1Description 2. Color : uniform, no mottling 3. Odor : characteristic of the formulation; no disagreeable odor . 4. Taste.: if sweet, 5.Determination of total sugar(if added).. 6. Determination of Reducing sugar/Non-reducing sugar (if added) B. Phytochemical assessment : Particle size Identification: Microscopic characters (if vegetable parts are used as ingredients ) ; TLC/HPTLC/HPLC/LC-MS (any one of all) 12

13. 3.Test for heavy/ toxic metals – Lead, Cadmium, Mercury, Arsenic 4. Microbial contamination - Total bacterial count ,Total fungal count 5. Test for specific pathogen - E.coli ,Salmonella spp., S.aureus , Pseudomonas aeruginosa 6.Pesticide residue - Organochlorine pesticides, Organophosphorus pesticides, Pyrethroids 7. Test for Aflatoxins - B1, B2, G1, G2 C. Physical evaluation : 1.Total ash 2.Acid- insoluble ash 3. Water- soluble extractive 4. Alcohol -soluble extractive 5. pH of 5% aqueous solution. 6. Volatile oil determination 7. Loss on drying at 105 °C. 13

14. D. Pharmaceutical parameters : 1. Hardness : Force required to break a tablet in a diametric compression test. Determined using Monsanto hardness tester or Pfizer hardness tester. limits: standard compressed tablet 5-8 kg/cm². 2. Friability :measures physical strength of the tablet on exposure to mechanical shock and attrition. Roche friability tester is used. Limits: % friability 0.5 – 1.0%. 3.Thickness : micrometer or vernier callipers is used. Limits: ±5% of the standard value. 4. Weight variation: Analytical balance I.P limits : If the average weight of the tablet is : 84mg or less - ± 1% 84 – 250 mg - ± 7.5% > 250mg - 5% 14

15. 5. Drug content : if possible 6. Content uniformity: random sampling 30 tablets. Perform assay for any 10 tablets individually. If the drug content in 9/10 tablets is within the specified limits 85-115% of the label claim then the batch passes. The assay of the 10 th tablet should lie between 75-125%. 7. Disintegration time: not more than 35 minutes, except for tablets formulated with guggul not more than 60 minutes. 7. Dissolution test: if possible. 15

16. Thank you 16