PHARMA SCIENCE MONITOR AN INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES FORMULATION DEVELOPMENT AND EVALUATION OF UNIT MOULDED POLYHERBAL JELLY USEFUL IN MEMORY ENHANCEMENT Bhoomika Shah, Bhavesh Nayak and Rashmi Gaudani Shree Swaminarayan Sanskar Pharmacy College, At & post Zundal, Ta. Dist. Gandhinagar-382 421. ABSTRACT The primary objective of this study was conducted with a view to formulate and evaluate the unit moulded jelly containing herbal medicaments and to optimize the dosage form that will have extra beneficiary learning and memory enhancing effect without any side effects. In the present investigation the hydroalcoholic extracts of Bacopa monniera and Evolvulus alsinoides drugs were complexed with betacyclodextrin for their taste masking and then formulated into jelly using natural gelling agent pectin with varying concentration. All the eight formulation (F1 to F8) under study was showed comparable appearance, ph, and viscosity. The optimized formulation was found to be stable for the period of 1 month as per ICH guidelines. Keywords: Taste masking agent, Herbal drugs, Jelly formulation. INTRODUCTION Memories are central to our individuality. What each of us remembers is different from what others remember, even of situations we have been in together. Yet, in our distinct ways, all of us remember events, facts, emotional feelings and skills - some for a short time, others for a lifetime. [1] Memory is the ability of individual to record sensory stimuli, events, information, etc. retain them over short or long periods of time and recall the same at later date when needed. Poor memory, lower retention and slow recall are common problems in today s stressful and competitive world. While we all complain about our memories, they are in the most part pretty good, only starting to fail in old age or certain neurological diseases. Age, stress, emotions are conditions that may lead to memory loss, amnesia, anxiety, high blood pressure, dementia, or to more ominous threats like schizophrenia and Alzheimer s disease (AD). Although various synthetic drugs for memory enhancement are available, side effects associated with them make their use limited. In the recent years, there has been a rise in the interest of scientific community and pharmaceutical laboratories to explore the therapeutic benefits of herbs to improve memory. [2] Polyherbal preparations are generally the mixtures of extracts, juices, www.pharmasm.com IC Value 4.01 2723
pulps, secretions, exudations or powders of medicinal herbs in solid, liquid or semisolid forms with or without a suitable base. The present study was aim towards the development of oral jelly formulation which will be unit mould containing polyherbal ingredients. Jelly can be defined as a soft, semisolid food substance with a resilient consistency, made by the setting of a liquid containing pectin or gelatin or by the addition of gelatin to a liquid, especially such a substance made of fruit juice containing pectin boiled with sugar. These are transparent or translucent nongreasy semisolid preparations meant for internal application. [3] Bacopa monniera is a small creeping herb with numerous branches, small oblong leaves and light purple or small and white flowers, with four or five petals. The herb is from a family Scrophulariaceae. It is found in wetlands throughout the Indian subcontinent in damp and marshy or sandy areas near streams in tropical regions. [4] Evolvulus alsinoides is a perennial herb with a small woody and branched rootstock growing throughout tropical and subtropical regions of the world, expanding through grasslands up to an elevation of 6,000 feet. [5] It (dwarf morning glory) is belonging to the family Convolvulaceae. [6] MATERIALS AND METHODS Materials Bacopa monnieri L. & Evolvulus alsinoids L. herb powders were purchased from Dhanvantari Ayurvedic Store, Ahmedabad, India in a month of December 2011. Pectin was purchased from Loba Chem. Mumbai, India. Citric acid was purchased from Seva Fine Chemicals, Ahmedabad. All the other chemicals used were of high analytical grade. Preparation of Bacopa monnieri & Evolvulus alsinoids extract The extraction was done by cold maceration method. First, the powdered plant material was macerated with mixture of Alcohol & Water (70:30) in a round bottom flask for 24 hours with occasional shaking. After 24 hours, the solvents were distilled off, the extract was then concentrated on water bath and then extracts were collected. Preparation of oral jelly All the ingredients were weight accurately. In one beaker, sugar syrup was made by adding sugar in hot water that act as bulking agent in the formulation and also provides body to the jelly. Then in this solution pectin was added with constant stirring & www.pharmasm.com IC Value 4.01 2724
heated to dissolve pectin completely to achieve desired stiffness. When pectin was completely dissolved, propylene glycol and citric acid were added with constant stirring to enhance softness of the jelly and to maintain ph respectively, and then boiled for few minutes. After boiling pectin solution, the scum was removed and sodium benzoate for better preservation was dissolved in water & added to pectin solution, mixed thoroughly and uniformly. Herbal drug extracts were weight accurately, dissolved in little amount of water and added before jelly is allowed to set, mix thoroughly. These whole solutions was transferred in to moulds and then allowed it for cooling and settling undisturbed by proper covering the moulds to avoid exposure to outer environment. After the jelly was set, it was tasted. Because of presence of herbal drug extracts, the taste was very bitter, so firstly had to mask the bitter taste. For taste masking, firstly complexation of herbal drug extract with betacyclodextrin was done by triturating them for 1 hr, then extract was concentrated & the free flowing complexed drug powder was obtained. Then it was subjected to same above procedure (1-6). After the jelly was set, it was wrapped in to the butter paper and stored in dry place. Evaluation parameters for formulation Appearance The prepared jelly was inspected visually for clarity, colour and presence of any particle. The test is important regarding patient compliance. ph [7] The ph of all the jelly was determined using digital ph meter. 0.5 g of the weighed formulation was dispersed in 50 ml of distilled water and the ph was noted. The standard ph of the jelly was 3-3.4. Determination of Viscosity [8] Viscosity of the jelly was carried out by using (LV) Brookfield viscometer (Dial type). As the system is non-newtonian spindle no. 4 was used. Viscosity was measured for the fixed time 2 min at 0.3 rpm. Viscosity determination of jelly was done by Brookfield viscometer (Dial type). Factor = 20 M M = 1000 www.pharmasm.com IC Value 4.01 2725
The viscosity was calculated by following relation: Viscosity in centipoises = Dial reading Factor The factor in above relation is found in factor finding chart provided by manufacturer of Brookfield viscometer. Stability Studies Stability study was conducted as per ICH (International Conference on Harmonization) guidelines. Stability studies of prepared jelly at Room temperature (25±2 C, 60±5% RH) and accelerated temperature condition (40±2 C, 75±5% RH) were carried out for one month and the formulations were analyzed for the changes in the physical parameters like appearance, ph, viscosity, sugar crystallization and stiffness at 15 and 30 days. TABLE 1: FORMULATION BATCHES OF DIFFERENT JELLY PRODUCTS Ingredients F1 F2 F3 F4 F5 F6 F7 F8 Pectin 2% 2% 2.5% 3% 3% 3% 3% 3% Citric acid 1% 1% 1% 1% 1% 1% 1% 1% Sugar syrup 60% - 67% 67% - 70% 80% 90% Raspberry - 60% - - 67% - - - syrup Water 30% 30% 20% 20% 20% 18% 9% 9% Propylene 3% 3% 3% 3% 3% 3% 3% 3% glycol Sodium 0.01% 0.01% 0.01% 0.01% 0.01% 0.01% 0.01% 0.01% benzoate Color - - - - - - - - Flavour - - - - - - - - B. monnieri 1% 1% 1% 1% 1% 1% 1% 1% E. alsinoids 1% 1% 1% 1% 1% 1% 1% 1% www.pharmasm.com IC Value 4.01 2726
RESULTS AND DISCUSSION The prepared jellies were evaluated with different parameters such as appearance, ph, and viscosity. The results are recorded in table 2. TABLE: 2 EVALUATION PARAMETERS FOR FORMULATION Formulations Appearance ph Viscosity (cps) F1 Transparent 3.5 640000 F2 Syrupy 3.8 600000 F3 Opaque 3.4 588000 F4 Opaque 3.6 580000 F5 Opaque 3.5 624000 F6 Transparent 3.2 590000 F7 Transparent 3.4 552000 (Sugar crystallization) F8 Transparent (Sugar crystallization) 3.3 604000 All the eight batches of prepared jelly were subjected to the evaluation for the appearance, ph, and viscosity. The appearance of formulation F3-F8 was transparent in nature, but F3 & F4 showed the presence of particle and F7 & F8 showed sugar www.pharmasm.com IC Value 4.01 2727
crystallization and the other formulations were white, opaque in appearance. The F6 was perfect, elegant, and transparent in appearance. The formulation F6 showed the ph within the range of standard ph range (3-3.3) of the jelly and the other formulations showed higher ph. The results of ph measurement are indicated in table 3. The viscosity of all formulations (F1 to F8) was determined using Brookfield viscometer (dial type). The results indicated that formulations were found uniform in consistency. Viscosity of formulation F6 was found optimum as it dissolved in the solution of ph 6.8 buffers up to six minute. The results of viscosity measurement are indicated in table 3. From the observations of various parameters that the formulation F6 containing 3% Pectin as gelling agent showed acceptable values as compared to the others. Hence, it was selected for further evaluation. TABLE: 3 STABILITY OF THE OPTIMIZED FORMULATION (F6) Days Appearance Viscosity ph Stiffness Sugar crystallization Room Temperature 15 Transparent 585000 3.40 Yes No 30 Transparent 568300 3.95 Yes No Accelerated Temperature 15 Transparent 495000 3.30 Yes No 30 Transparent 413600 3.20 Yes No As per stability data of the jelly, F6 formulation was found to be stable at room temperature. It became very sticky when kept at accelerated temperature, but even at the accelerated temperature if it is kept in covered or enclosed condition; there was no or little change in consistency. The results are recorded in table 4. www.pharmasm.com IC Value 4.01 2728
CONCLUSIONS The present study demonstrates the herbal extracts of Bacopa monniera and Evolvulus alsinoides, were successfully formulated in the jelly formulations. In formulation development, taste masking of bitter herbal drugs was a big challenge and that was solved by making complex with betacyclodextrin. All drugs extracts, which are used in the dose range are safe for consumption and can be swallowed without any risk of systemic side effects. The prepared jelly formulation will be a substitute over the other preparation available in the market in near future. For giving more prominent memory enhancing effect, it is need to use more dose of drugs up to its maximum extent, within that dose, most important things are to mask their bitter taste and to formulate into jelly. It is also preferable to do preclinical and clinical study of the prepared jelly formulation in future with different learning and memory enhancing models. ACKNOWLEDGEMENTS The authors are grateful to Shree Swaminarayan Sanskar Pharmacy Collage and the management to provide such facilities and stage to carry out the research work in a smooth way. REFERENCES 1. Alan Baddeley, Learning & Memory Brain Campaign, www.braincampaign.org/common/docs/files/2769/echap11.pdf 2. Vasudevan M and Parle M: Pharmacological actions of Thespesia populnea relevant to Alzheimer s disease. Phytomedicine 2006; 13: 677-687. 3. James CB: Encyclopedia of pharmaceutical technology, Gel and jellies, Edition 11, Vol II, 327-343. 4. Russo A and Borrelli F: Bacopa monniera, a reputed nootropic plant: an overview. Phytomedicine 2005, 12: 305-317. 5. Kapoor LD: CRC Handbook of Ayurvedic Medicinal Plants. Boca Raton, CRC Press, 2001: 184. 6. Austuin DF: Evolvulus alsinoides (Convolvulaceae): An American herb in the Old World. Journal of Ethnopharmacology 2008; 22: 713. www.pharmasm.com IC Value 4.01 2729
7. Rawlins EA: Bentley s text book of pharmaceutics, Bailleere Tindall, London, Edition 18 1995: 19-24. 8. Rawlins EA: Bentley s text book of pharmaceutics, Bailleere Tindall, London, Edition 8 1982: 546. For Correspondence: Bhoomika Shah Email: bhoomikashah89@gmail.com www.pharmasm.com IC Value 4.01 2730