IRJET- Recrystallization of Paracetamol and Dronedarone for Improvement of Pharmaceutical Parame

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Recrystallization of Paracetamol and Dronedarone for Improvement of Pharmaceutical Parameter Gita Sahu1, S. N. Sakarkar2, Ritika Singh3, Sarita Sahu4 1Department

of Pharmacy, Shri Rawatpura Sarkar University, Raipur-492015, Chhattisgarh, India of pharmacy, G H Raisoni University Saikheda , Nagpur-440022, Maharashtra, India 3Department of Pharmacy, Shri Rawatpura Sarkar University, Raipur-492015, Chhattisgarh, India 4Department of Pharmacy, Shri Rawatpura Sarkar University, Raipur-492015, Chhattisgarh, India -------------------------------------------------------------------***----------------------------------------------------------------2School

Abstract: In these studies that are based on compression of control drug and Recrystallized drug. We are choosing mainly two drugs which are commonly used in the medication system. First are most common drug of paracetamol and second of the most life threshing drug Dronedarone. Paracetamol also called acetaminophen which acts as a cox-1 inhibitor and Dronedarone have classified anti-arithmetic drug that regulate the normal rate rhythm.

Control drug have exhibit low solubility and a very low dissolution rate in solvent, which can control its bioavailability and pharmacological effect. For the Recrystallization we choose the solvent methanol and aqua distilled water. And compare the control drug dissolution and Recrystallized drug dissolution. Recrystallized drug crystals have more solubility and dissolution properties as compare to control drug. That show the good Pharmaceutics and pharmacodynamic activity Keywords: Paracetamol1, Drondraon2, Recrystallization4, Dissolution5, Solubility6.

Dissolve in desire of solvent at boiling point

Colored impurities (yes) add activated carbon (removes colored impurities)

Are insoluble impurities present yes Gravity filter hot solution (removes insoluble impurities)

After cool slowly to room tem. Then in Ice bath crystallize

Methanol3,

1. Introduction Separate crystals from solution (removes sol impurities)

Recrystallization process defines the drug purity and physical properties like crystal shape and size, particle habit. Thereupon, crystalline variety is accountable for a broad of pharmaceutical formulation problems, such as bio-in equivalence, as well as physiochemical unsteadiness of the medicament in their dosage formulation. Solid organic compounds when screened from organic Reaction area a few times pure. They are usually adulterant with minor quantity of other compounds or impurities, which are created in conjunction with the preferred artifact. The purification of impure crystalline compounds is usually depending by crystallization from a proper vehicle or in some cases from a mixture of two solvent or more dissolution. The purification of solids by crystallization is depend upon their nature of solubility in a given dissolution solvent. [ChewW,S.P.(2010)]

(Precipitated or vacuum filtration)

wash with a suitable of ice-cold solvent

Allow crystals to dry to content weight

Determine wt, mp % yield, spectra, etc

GENERAL STEP’S OF CRYSTALFORMATION

1. MATERIAL AND METHOD

Impure Solid to be crystallized

The drug Paracetamol and Dronedarone was used for Recrystallization. Chemical name of PCM is acetaminophen and this drug is used to treat Non Steroidal Antiinflammatory drugs. It is general used for mild to moderate ache release. [Nagy ZK, B.

Do solubility tests to find good crystallization solvent (high solubility hot, low solubilitycold)

R. (2012)] 2.

Paracetamol is presented as a generic drug with trade names including Tylenol and Parasol, among others.

[Yang Y, N. Z. (2015)]3.

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The second drug selected Dronedarone is Class III antiarrhythmias drugs that mechanism to re- establish the normal heart rhythm in patients with spastic or constant atrial twitching. Atrial twitching is a regular persistent arrhythmia there the management mostly focus on stroke avoidance and symptom management. [Raphael M, R. S. (1999)]4. Arrhythmia is manage by plus control, rate of rhythm manage, avoidance of thromboembolic procedures, and treatment of the basic [JiangX,L.D.(2016)]5. cardiac disease Amiodarone, Dronedarone is a same categories drug have same mechanism of action multichannel blocker based working to manage heart rate and rate in atrial twitching[Yadav AV, Y. V. (2008)] 6. Antiarrhythmics categories of drug works based under the inhibiting β-adrenergic receptors blocking and multichannel (potassium, sodium and calcium ion channels)[Mahanty S, S. J. (2010)] 7.

Fig. 2 : Graph represent the data of ph values of Recrystallized crystal of Paracetamol at different Pharmaceutical limits such as different increasing temperature 25°C , 45°C and 65°C and by preparing crystal with polymers and surfactant.

2. EXPERMANTAL RESULT AND DISCUSSION

(a)

Solubility surplus amount of drug in 30 µl water matrix were added in the container. These preparation were kept in an incubator at the temperature 370C for 72 hr to attain equilibrium [Kallies B, K. A. (1993)] 9. After

(b)

pH of drug Sample determined by dissolving

10mg of drug in 3ml of Distilled water. For the determination of pH using Electrometric pH meter at invariable temperature before using this the pH meter it was calibrated using by different pH buffer solution pH4.0 and pH 9.2 and After then the electrode was resin with distilled water the electrode was directly dipped into a prepared solution and stable evaluation reading. [Paradkar AR, P. A. (2010)] 8.

the three day solution was filtered and diluted up to 3 ml with distilled water and subjected for quantification of drug by UV spectrophotometric method at the maximum wavelength(ℷ max).ME, A. (2002)10.

Solubility graph of Recrystallized crystal of Dronedarone at different temperature, polymer, surfactant Concentration/µg

ph

pH graph of Recrystallized crystal of Dronedarone at different temperature ,Polymer ,surfactant 7 6.5 6 5.5

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1.2 1 0.8

Fig. 3: Graph represent the data of solubility of Recrystallized crystal of Dronedarone at different pharmaceutical parameter such as respectively increasing temperature 25°C, 45°C and 65°C and by preparing crystal with polymers and surfactant

Fig. 1: Graph represent the data of pH values of Recrystallized crystal of Dronedarone at different pharmaceutical parameter such increasing temperature such as 25°C, 45°C and 65°C and by preparing crystal with polymers and surfactant.

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Concentration/µg

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Solubility graph of Recrystallized crystal of PCM at different temperature, polymer and surfactant

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Dissolution graph of Recrystallized Crystal of Dronedarone at different temperature and with different polymer and surfactant

1.4 1.2 1 0.8

Contro l 1

25ᵒC 45ᵒC

0.5 Fig. 4: Graph represent the data of solubility of Recrystallized crystal of Paracetamol at different pharmaceutical parameter such as different temperature 25°C , 45°C and 65°C and by preparing crystal with polymers and surfactant.

0

PEG6

0 20 40 60 80 100 120 140 Time

(C) In-vitro dissolution testing offers a suitable and economical resource to establish absorption and bioavailability of preparation of the standard drug.

Outline of drug release for costal of Aceclofenac and Paracetamol drug determined has a delivery system Powerful utility and thus provides important insight into its in vivo behavior. The in- vitro release profile for costal as well aware a pure drug was performed USP xxii type dissolution apparatus [Patil BP, G. V. (2011)] 11 .

00 HPMC

Figure 5: Graph represents the data of dissolution profile of Recrystallized crystal of Dronedarone at different pharmaceutical parameter such as different respectively temperature and by preparing crystal with polymers and surfactant.

Dissolution graph of Recrystallized crystal of paracetamol at different temperature and with polymer surfactant Concentration/µg

Take 100mg of crystal sample was added to 900mI.1N HCL at normal body temperature 37±0.5°C and mixed at 50rpm. 1ml of liquid sample was taken at time respectively 5-10 mints interval.

The taken volume was replaced with the same volume of dissolution medium and maintained the sink condition. The absorbance of the Preparation was analyzed at ℷ max

Control

25ᵒC .

45ᵒC

PEG6 00 HPMC

Fig. 6: Graph represents the data of dissolution profile of Recrystallized crystal of Paracetamol at different pharmaceutical parameter such as Different temperature and by preparing crystal with polymers and surfactant .

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3. Conclusions Recrystallized crystal of paracetamol and Dronedarone were prepared by solvent evaporation method paracetamol with distilled water and Dronedarone used in hydro methanol as a solvent.

Various test like pH, Solubility and dissolution test predict a vital increase in the solubility and dissolution rate of Dronedarone and paracetamol Recrystallized crystals as compare to pure paracetamol and Dronedarone .After the Recrystallization of drug parameter ware affected solubility, pH, Drug release increased as compare to pure drug means showing improved pharmaceutical parameters.

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[2] Nagy ZK, B. R. (2012). Advances and new directions in crystallization contro. Annu Rev Chem Biomol Engineering. 55(3), 062011- 081043.

[3] Yang Y, N. Z. (2015). Advanced control approaches for combined cooling/anti solvent crystallization.

Chemical Engineering & Science.9 (2), 1124-1136.

[4] Raphael M, R. S. (1999). Sunflower protein precipitation in a tubular precipitator. Can Journal of Chemical Engineering. 77 (3), 540-554.

[5] Jiang X, L. D. (2016). Membrane assisted cooling crystallization, AIChE.62 (3), 829-841.

[6] Yadav AV, Y. V. (2008). Designing of pharmaceuticals to improve physicochemical properties by spherical crystallization techniques. Journal of Pharmacy & Res. 22 (1), 105-112.

[7] Mahanty S, S. J. (2010). Particle Design of drugs by Spherical Crystallization Techniques. Inte J Pharm Sciences and Nanotechnology.13 (7), 0974-3278.

[8] Paradkar AR, P. A. (2010). A novel particle engineering technique. Asian J Pharm.4 (1), 09738398.

[9] Kallies B, K. A. (1993). Solidification by crystallization in drops international workshop for industrial crystallization. Breman, Germany. 18 (4), 1678-4383.

[10] ME, A. (2002). Pharmaceutics-The Science of Dosage form Design. 2nd Ed. New York: Churchill Livingstone. 22 (5), 1121-2312.

[11] Patil BP, G. V. (2011). Spherical Agglomeration- Direct Tabletting Technique. Inte Research J of Pharmacy.11 (2), 3

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