piyush kardak

Evaluation of Effects of Concomitant Consumption of Beverages On The Release Profiles of Some Drugs : 

Evaluation of Effects of Concomitant Consumption of Beverages On The Release Profiles of Some Drugs By: Piyush A. Kardak Kamla Nehru College of Pharmacy, Butibori,Nagpur

Introduction: 

Introduction Recent advances in pharmaceutical technologies, polymer sciences and analytical tools have enabled design of smarter drug delivery systems. Various formulation strategies are employed for optimizing the therapeutic efficiency and/or minimizing side effects of drugs designed as smart dosage forms. Such techniques used for extended release or programmed release or targeted release have generated many patents. They not only offer the manufacturers an edge above the competitors but often offer obvious advantages to the patients also due to reduced dose frequency, reduced total dose consumption and minimal exposure of the non-target tissues to pharmacological effects. Most of the patients traditionally consume the medicines with one or more of the beverages including the health drinks with complex compositions. It is known fact that there is a great variation in the quantity and the regimen followed for consumption of these beverages.

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There are possibilities of probable interactions between any of the components of these beverages and the formulation ingredient including the drug candidate. Such interactions have so far been neglected and only a few like those with the grapefruit juice have been reported. A few reports also cite the dramatic alterations in the release profiles of commonly used OTC type drugs due to concomitant consumption of alcoholic beverages. Unlike the drug-drug or food drug interactions however, the data available on probable drug –beverage interactions is very limited. Classically any of the interactions can be classified as follows; Drug-Drug Drug –Food Drug- Chemical Drug-Disease The net effect of any type of drug interaction is generally, Quantitative i.e increased or decreased therapeutic response Rapid or slower effect Precipitation of newer or increased adverse-effects.

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Most of these adverse reactions alter the efficacy of drug e.g. haemorrhagic tendency of Warfarin when phenylbutazone is given subsequently, Tetracycline when concomitantly administered with food, antacid or mineral supplements containing metal ions i.e.especially calcium. Moreover, such adverse interactions may offset the advantages /benefits of drug delivery from specially designed formulations which act as smart delivery systems. Hence, there is great need to explore the possible drug-beverage interactions and develop tools to elucidate their probable mechanisms. Such data would help to redefine the formulation strategies for conventional and/or novel drug delivery systems and recommend altogether new dose regimens for the patients. A screening is also needed to know more details about the composition of beverages including various food drinks, social drinks which are consumed routinely.

Need of Work:: 

Need of Work: The Indian population generally consumed food drinks, social drinks. The most common beverages consumed by Indian population include; Tea, Coffee, Buttermilk, Aerited , non- Aerited etc. These beverages are consumed on large scale and people are yet to be aware of the possible interaction of these beverages with commonly used drugs which are available as over the counter (OTC) product viz. such as analgesic, anti- inflamentry agent etc. This work aims to focus on major issues of altered release or absorption pattern of some drugs that can be improved by minimizing side effect.

Objective:: 

Objective: The present work aims at following; Chareterisation of drug candidate for identify purity,quality . Chareterisation of selected dosage form as per pharmacopoeia. Standardisation of composition and method of preparation of bevarages /food drinks to be used as modified dissolution media. Invitro / evaluation of effect of selected bevarages on drug release patten from selected dosage form by compendia or non compendia method disintegration time, invitro dissolution profile. Invivo evalution of effect of selected bevarages on excerection of drug from selected dosage form by urine analysis. Establishment of co-relation between invitro and invivo data.

Plan of Work:: 

Plan of Work: Literature survey for establishing the need and scope of the proposed work area Selection of desirable dosage form of drug candidate and commanly used bevarages Standardization of drug candidate

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Physicochemical Analytical 1.Melting point 1.Infra-red spectroscopy 2.Ultra-violet spectroscopy Standardization of Beverages

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Milk Coffee Tea Aerited Non- Aerited 1.Temperature 1.Organoleptic 1.Organoleptic 1..Volume 1.Volume 2.Volume properties properties 2.Composition 2. Composition 2.Volume 2.Volume 3.Flavour 3. Flavour 3.Temperature 3.Temperature 4.pH 4.pH 4.Composition 4.Composition 5.pH 5.pH

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In vitro dissolution studies of selected dosage from using modified dissolution media prepared using standardized beverages using USP Dissolution Apparatus II. Analysis of release kinetics for probable effects on release pattern using statistical tools. In-vivo evalution of concomittant consumption of beverages of drug candidate by urine analysis.

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Interpretation of data Developed of IVIVC

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Experimental: List of Material: Sr No. Name of Drug/Beverages Supplied/ manufactured by 1. Diclofnac Sodium Zim laboratories, kalmeshwar , Nagpur 2. Diclofenac Sodium Tablets Renumed Pharmaceutical lab,Thane 3. Milk Dinshaws Dairy Foods, Nagpur 4. Tea Hindustan Unilever Ltd, Silvassa 5. Coffee Nestle India limited ,New Delhi 6. Mazza Brindawan Beverages Pvt. Ltd.,Uttar Predesh 7. Coca-cola Narmada Drinks Pvt. Ltd, . Chhatisgarh

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List of Equipments / Instruments: Experimental was broadly divided into following parts: Characterization of drug candidate from NSAID’s for identity, purity and quality. Standardization of selected dosage form as per monograph. Standardization of composition and method of preparation of beverages/ food drinks to be used as modified dissolution media . Sr. No. Name of Equipments Make Model 1. UV-Spectrophotometer Shimadzu UV-1800 2. Tablet DisintegrationTester Eletrolab TDT-08L 3. Dissolution Apparatus Veego ----- 4. Digital pH meter Hanna Hanna 002 5. Electronic weighing balance Conteth -CB CA-123

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4. In-vitro evaluation of effects of selected beverages on release characteristics of drug candidate. 5. In-vivo evaluation of effects of selected beverages on absorption /excretion of drug candidate by urine analysis. 6. Establishment of co-relation between in-vitro and in-vivo data. Characterization of drug: The characterization of drug was carried out by conducting various tests including Organoleptic properties Melting range determination Spectral characteristics- Ultraviolet spectroscopy (UV), Infrared spectroscopy(IR)

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Organoleptic properties Organoleptic properties viz. color, odor and taste of drug powder were recorded as soon as the gift sample of drug was received. Color was noted by visual observation, odor was checked for any peculiar property and taste of sample was tested by placing a pinch on the back of the tongue. Determination of melting range Melting point was determined using glass capillary method. The programmable melting point apparatus was used. Drug filled capillary was placed in melting point apparatus containing silicon oil as heating medium & melting range was noted .

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Spectral analysis of drug i ) Determination of λmax in UV range- The stock solution of Diclofenac Sodium (100µg/ml) was prepared by dissolving accurately weighed 10 mg in distilled water. The drug was first dissolved in 5 ml of ethanol and then final volume was made upto 100 ml with distilled water. The stock solution was suitably diluted with respective solvents to give solution of 10µg/ml concentration. These solutions were scanned over the range of 200-400 nm and the λmax values were recorded. ii) Preparation of standard curve of drug 1. Preparation of standard curve in distilled water - The stock solution (100 µg/ml) was prepared by dissolving accurately weighed 10mg of drug in distilled water. The solutions in the concentration range of 2-20 µg/ml were prepared by appropriate dilutions of the stock solution. The UV absorbances of these solutions were recorded at previously reported λmax value and calibration curve was plotted.

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Drug release ( in-vitro) : The in-vitro release of Diclofenac sodium from IR tablet was estimated using dissolution test carried out as under Dissolution test parameters- Dissolution test apparatus : USP XXII type II (paddle). Dissolution medium : 900 ml of distilled water Temperature of medium : 37 ±0.5 0 C Speed of rotating paddle : 100 rpm Sampling volume : 5 ml Sampling interval :5 min Duration of test :30 min The modified drug samples equivalent to 75 mg of Diclofenac sodium were placed in dissolution medium. Small qt. of solutions were withdrawn at predetermined intervals and were replaced with same volume of dissolution medium at each withdrawal. The solution were filtered through Whatman filter paper (No.41) & diluted appropriately before recording the absorbances at previously reported λmax value.

Observations:: 

Observations: 1) Melting Point of Diclofenac Sodium: 282 0 -284 0 C 2) pH of Beverages: Tea: Coffee: Aerited : Non- Aerited :

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3) Calibration Curve: Calibration curve of diclofenac sodium in plain water: Sr. No. Concentration( ppm ) Absorbance(abs) 1. 2 0.067 2. 4 0.125 3. 6 0.182 4. 8 0.235 5. 10 0.293 6. 12 0.371 7. 14 0.400 8. 16 0.498 9. 18 0.516 10. 20 0.544

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Dissolution Testing: 1. In Water: Sr. No. Time(min) Absorbance (abs) Concentration ( ppm ) % Drug Release(%) 1 5 0.009 0.17 3.06 2 10 0.013 0.2 3.60 3 15 0.041 1 18.00 4 20 0.047 1.2 21.60 5 25 0.077 2.2 39.60 6 30 0.089 2.8 50.40 7 35 0.104 3.1 55.80 8 40 0.105 3.2 57.60 9 45 0.109 3.3 59.40 10 50 0.120 3.8 68.40 11 55 0.116 3.7 66.60 12 60 0.117 3.7 66.60 13 65 0.107 3.4 61.20 14 70 0.095 2.9 52.20

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2. In Tea: Sr.No . Time (min) Absorbance(abs) Concentration( ppm ) % Drug Release 1 5 0.012 0.19 3.42 2 10 0.025 0.6 10.80 3 15 0.042 1.0 18.00 4 20 0.057 1.6 28.80 5 25 0.078 2.1 37.80 6 30 0.097 3.0 54.00 7 35 0.112 3.4 61.20 8 40 0.129 4.0 72.00 9 45 0.120 3.8 68.40 10 50 0.139 4.2 75.60 11 55 0.131 4.1 73.80 12 60 0.142 4.3 77.40 13 65 0.149 4.5 81.00 14 70 0.130 4.0 72.00

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3. In Coffee: Sr. No. Time(min) Absorbance (abs) Concentration( ppm ) % Drug Release(%) 1 5 0.019 0.4 7.2 2 10 0.031 0.7 12.60 3 15 0.051 1.4 25.20 4 20 0.072 2.0 36.00 5 25 0.085 2.3 41.40 6 30 0.098 3.1 55.80 7 35 0.110 3.3 59.40 8 40 0.095 2.9 52.20 9 45 0.125 3.9 70.20 10 50 0.120 3.8 68.40 11 55 0.138 4.2 75.60 12 60 0.132 4.1 73.80 13 65 0.145 4.4 79.20 14 70 0.105 3.2 57.60

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Reference: 1 . Beverly J. McCabe- Sellers, University of Arkansas Special from Bottom Line/Health November 1, 2008 2. www.fda.gov National Consumers League www.nclnet.org 3. Food and Drug Administration www.fda.gov 4.family doctor.org American Academy of Family Physicians 5.GL Amidon et al., Pharm Res Vol 12(3): 413-420, 1995 6.JS Kim et al., Molecular Pharmaceutics, Vol 3(6): 686-694, 2006 7.X Cao et al, Pharm Res Vol 23(8):1675-1686, 2006 8. www.fda.gov/cder/consumerinfo/druginteractions.htm 9. Davies, P. Oral Solid Dosage Forms. In Pharmaceutical Preformulation and Formulation, 2nd ed.; Gibson, M., Ed.; CRC Press LLC: Boca Raton, FL, 2004; p 379.

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10. Chuong , M.; Poirier, B.; Crosby, S.; Pidgeon , C. A Modified USP Disintegration Method to Simulate a Tablet Disintegrated in the Stomach When Taken with Cold Beverage or with Food. AAPS J . 2007, 9 (S2), 1687 11. Diclofenac sodium tablets. USP package insert. Interpharm Inc.: Hauppauge, NY; 2000. 12.Disintegration <701>. In United States Pharmacopeia and National Formulary USP 31–NF 26 ; The United States Pharmacopeial Convention, Inc.: Rockville MD,2008, p 266. 13. Text book of biopharmaceutics and pharmacokinetic by Bramhankar and Jaiswal , vallabh prakashan , page no. 204