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3958 Int J Pharm Sci Nanotech Vol 11; Issue 1 January February 2018

Research Article

Design, Optimization and Evaluation of Fast-Dissolving Oral Films of Ropinirole A. Srinivas1 and D.V.R.N. Bhikshapathi2* 1Mewar University, Chittorgarh, Rajasthan, India; and 2Vijaya College of Pharmacy, Hayathnagar (M), Hyderabad-501511, Telangana, India.

Received September 19, 2017; accepted November 15, 2017

ABSTRACT

The main objective of this study was to develop fast dissolving oral films of ropinirole HCl to attain quick onset of action for the better management of Parkinson’s disease. Twenty-seven formulations (F1-F27) of ropinirole oral dissolving films by solvent-casting method using 33 response surface method by using HPMC E15, Maltodextrin PEG 4000 by using Design of experiment software. Formulations were evaluated for their physical characteristics, thickness, folding endurance, tensile strength, disintegration time, drug content uniformity and drug release characteristics and found to be within the limits. Among the prepared formulations F4 showed minimum disintegration time 11 sec, maximum drug was released i.e. 99.68 ± 1.52% of drug within 10 min when

compared to the other formulations and finalized as optimized formulation. FTIR data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. The in vitro dissolution profiles of marketed product and optimized formulation was compared and found to be the drug released was 92.77 ± 1.52 after 50 min. Therefore, it can be a good alternative to conventional ropinirole for immediate action. In vitro evaluation of the ropinirole fast dissolving films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of ropinirole. The oral dissolving film is considered to be potentially useful for the treatment of Parkinson’s disease where quick onset of action is desired.

KEYWORDS: Ropinirole; Parkinson’s disease; Oral films; disintegration time, HPMC.

Introduction

Rapidly dissolving or quick dissolving dosage forms have acquired great importance in the pharmaceutical industry due to their unique properties and advantages (Liang and Chen, 2001; Borsadia et al., 2003). They undergo disintegration in the salivary fluids of the oral cavity within a minute, where they release the active pharmaceutical ingredient. The major amount of the active pharmaceutical ingredient is swallowed orally with the saliva where subsequent absorption takes place in the gastrointestinal tract (Klancke, 2003; Parakh and Gothoskar, 2003). The film is an ideal intraoral fast-dissolving drug delivery system, which satisfies the unmet needs of the market, is easy to handle and administer, maintains a simple and convenient packaging, alleviates unpleasant taste, and is straight forward to manufacture. Oral fast dissolving film (FDF) is one such novel approach to increase consumer acceptance by virtue of rapid dissolution, self-administration without water or chewing. The need for non-invasive delivery systems continues due to patient’s poor acceptance and compliance with existing delivery regimes, limited market size for drug companies and drug uses, coupled with high cost of disease management (Swapnil et al., 2012). Oral fast dissolving film rapidly

disintegrates and dissolves to release the medication for oromucosal and intragastric absorption (Bhupinder et al., 2011). When put on the tongue, this film disintegrates instantaneously, releasing the drug which dissolves in the saliva. Some drugs are absorbed from the oral, pharynx, and oesophagus as the saliva passes down into the stomach. In such cases, the bioavailability of the drug is significantly greater than that observed for conventional tablets (Revathi, 2007). Since the drug is directly absorbed into the systemic circulation, degradation in the gastrointestinal (GI) tract and first pass effect can be avoided (Koland et al., 2010). These dosage forms possess certain specific advantages like no need of water for disintegration, accurate dosing, rapid onset of action, ease of transportability, ease of handling, pleasant taste and improved patient compliance. It is widely accepted that the primary cause of Parkinson’s disease is a progressive degeneration of nigral dopamine neurons, which leads to a substantial decrease in the dopamine levels in the caudate nucleus and putamen (Hornykiewicz, 1987).

Ropinirole is a dopamine agonist of the non-ergoline class of medications. It is used in the treatment of Parkinson's disease and restless legs syndrome (RLS) (Debra, 2007). Fast dissolving films are the novel approach in oral drug delivery systems. It promises

International Journal of Pharmaceutical Sciences and Nanotechnology

Volume 11Issue 1 January – February 2018

MS ID: IJPSN-9-19-17-BIKSHAPATHI

3958

Srinivas and Bhikshapathi: Design, Optimization and Evaluation of Fast-Dissolving Oral Films of Ropinirole 3959

patient compliance especially in case of pediatrics and geriatrics patients. They can also be used when quick action is required. They possess many advantages over conventional dosage form and can also be used in cases of dysphagia, Parkinson's disease, mucositis or vomiting (Bala, 2013).

To provide the patients with the most convenient mode of administration, there is a need to develop rapidly dissolving dosage form, particularly one that disintegrates and dissolves/ disperses in saliva and can be administered without need of water. Fast dissolving films are useful in patients such as paediatric, geriatric, bedridden, or developmentally disable who may face difficulty in swallowing conventional tablets. So the patients would be benefited from acute treatment by using proposed drug delivery system. Thus, a fast dissolving film is a unique solid oral dosage form and has valuable advantages.

The present study is aim to formulate and characterize the fast dissolving oral films of ropinirole HCl for rapid onset of action in the management of Parkinson’s disease and also to improve the bioavailability of the drug.

Materials and Methods

Reagents

Ropinirole pure drug was generous gift from Aurobindo Pharma Limited, Hyderabad, India. Hydroxy Propyl Methyl Cellulose (E15) was received by Nectar life

sciences, Hyderabad, Maltodextrin DE6 and Aspartame was gifted from Matrix Labs, Hyderabad. PEG 4000, Sucralose, Pineapple flavor and Aspartame were purchased from SD FINE CHEM LTD, Mumbai. All other Chemicals used were of analytical grade.

Formulation of Ropinirole HCl Oral Dissolving Film

Fast-dissolving films of Ropinirole HCl were prepared by the solvent casting method. The composition is shown in Table 1.

The water soluble polymers (Hydroxy Propyl Methyl Cellulose (E15) and Maltodextrin DE6) were soaked in half quantity of distilled water for overnight to obtain a uniform dispersion. Aqueous solution I was prepared by adding plasticizer to above polymeric solution and was allowed to stir for 4 hours and kept for 1 hour to remove all the air bubbles entrapped. Aqueous solution II was prepared by dissolving the Ropinirole HCl, sucralose, aspartame in specific proportion in remaining amount of distilled water (Salman et al., 2014).

Both aqueous solutions I and II were mixed and stirred for 1 hour and kept for 30min for sonication. Then the mixture solution was casted onto a plastic Petri dish having surface area of 63.5cm2 and it was dried in the oven at 50 oC for 24 hour. The film was carefully removed from the Petri dish, checked for any imperfections, and cut according to the size required for testing (2 × 2 cm2).

TABLE 1

Formulation of fast dissolving oral films Containing Ropinirole HCl.

F. NO Ropinirole

(mg) HPMC E 15 (mg)

Maltodextrin (mg)

PEG 4000 (mg)

Sucralose (mg)

Aspartame (mg)

Pine apple Flavor (ml)

Water (ml)

F1 16 150 160 80 40 20 0.1 Q.S F2 16 180 160 40 40 20 0.1 Q.S F3 16 150 150 80 40 20 0.1 Q.S F4 16 150 120 80 40 20 0.1 Q.S F5 16 150 160 40 40 20 0.1 Q.S F6 16 200 150 40 40 20 0.1 Q.S F7 16 150 150 80 40 20 0.1 Q.S F8 16 200 150 80 40 20 0.1 Q.S F9 16 150 160 80 40 20 0.1 Q.S

F10 16 200 160 60 40 20 0.1 Q.S F11 16 180 120 40 08 20 0.1 Q.S F12 16 180 120 80 40 20 0.1 Q.S F13 16 180 160 60 40 20 0.1 Q.S F14 16 180 150 60 40 20 0.1 Q.S F15 16 180 120 60 40 20 0.1 Q.S F16 16 180 120 40 40 20 0.1 Q.S F17 16 180 160 40 40 20 0.1 Q.S F18 16 180 150 80 40 20 0.1 Q.S F19 16 200 160 40 40 20 0.1 Q.S F20 16 180 160 80 40 20 0.1 Q.S F21 16 200 160 60 40 20 0.1 Q.S F22 16 200 150 40 40 20 0.1 Q.S F23 16 200 120 80 40 20 0.1 Q.S F24 16 150 120 60 40 20 0.1 Q.S F25 16 200 140 60 40 20 0.1 Q.S F26 16 150 140 60 40 20 0.1 Q.S F27 16 180 140 60 40 20 0.1 Q.S


Response Surface Methodology (Montgomery and Douglas, 2005)

Twenty seven formulations (F1-F27) were prepared by solvent casting method using 33 response surface method where 33 indicates 3 variables and 3 levels of polymers (HPMC E15, Maltodextrin) of different grades and plasticizer (PEG 4000) (low, middle and high concentrations) by using Design of experiment software (ReliaSoft software product).

Evaluation of Films Thickness uniformity (Prabhu et al., 2011): The

thickness of the patch was measured using digital Vernier Calliper with a least count of 0.01 mm. The thickness was measured at different strategic points of the film and average was taken and SD was calculated.

Weight uniformity (Kumar et al., 2005): Weight variation is studied by individually weighing randomly selected films and calculating the average weight. And standard deviation was calculated.

Drug Content uniformity (Mashru et al., 2005): Drug content determination of the film was carried out by dissolving the films of required size in pH 6.8 phosphate buffer using magnetic stirrer for 1hour. The drug concentration was then evaluated spectrophotometrically at λmax of 250 nm. The determination was carried out five times for all the formulations and average with standard deviation was recorded.

Folding endurance (Bagul and Gujar, 2010): Folding endurance was determined by repeated folding of the film at the same place till the strip breaks. The number of times the film is folded without breaking was computed as the folding endurance value.

Surface pH of film (Prabhu et al., 2011): The pH was determined by dissolving a film in 2 mL of pH 6.8 phosphate buffer and then the pH of the obtained solution was measured by pH meter. The average of three determinations for each formulation was done.

Tensile strength (El-Setouhy et al., 2010): Tensile strength is the maximum stress applied to a point at which the strip specimen breaks. Film strip of dimension 2 × 2 cm2 and free from air bubbles or physical imperfections was held between two clamps positioned at a distance of 3 cm apart. A cardboard was attached on the surface of the clamp via a double sided tape to prevent the film from being cut by the grooves of the clamp. During measurement, the strips were pulled at the bottom clamp by adding weights in pan till the film breaks. The force was measured when the films broke. It is calculated by the applied load at rupture divided by the cross-sectional area of the strip as given in the equation below:

Tensile strength = Load at Failure

Strip thickness ×Strip width

In vitro Disintegration Time (Rawas-Qalaji et al., 2006): The film size required for dose delivery (2X2 cm2) was placed on a glass Petri dish containing 10 ml of pH 6.8 phosphate buffer. The time required for the film to break was noted as in vitro disintegration time.

In vitro drug release studies (Amit et al., 2009): Dissolution profile of fast dissolving films of ropinirole HCl was carried out in a beaker containing 30ml of the stimulated salivary fluid pH (6.8) as a dissolution medium, maintained at 37 ± 5ºC. The medium was stirred at 100rpm. Aliquotes of the medium were withdrawn at regular intervals of 1 min. And the same amount was replaced with fresh medium. Samples were analyzed for cumulative percentage drug release spectrophotometrically at 250nm. Three trials were carried out for all the samples and average was taken.

Introduction to Design of Experiments (DOE) (Schwartz and Connor, 1996): DOE is an essential piece of the reliability program pie. It plays an important role in Design for Reliability (DFR) programs, allowing the simultaneous investigation of the effects of various factors and thereby facilitating design optimization. This article introduces the concept of DOE. Future articles will cover more DOE fundamentals in addition to applications and discussion of DOE analyses accomplished with a soon-to-be-introduced ReliaSoft software product.

Drug Excipient Compatability Studies

The drug excipient compatibility studies were carried out by Fourier Transmission Infrared Spectroscopy (FTIR) method and Differential Scanning Colorimetry (DSC) method.

Fourier Transform Infrared Spectroscopy (FTIR)

FTIR spectra for pure drug, physical mixture and optimized formulations were recorded using a Fourier transform Infrared spectrophotometer. The analysis was carried out in Shimadzu 8400 S -

IR Affinity 1 Spectrophotometer. The IR spectrum of the samples was prepared using KBr (spectroscopic grade) disks by means of hydraulic pellet press at pressure of seven to ten tons.

Scanning electron microscopy: The shape and surface morphology of the films was examined using Hitachi S-3700 scanning electron microscope (Japan) (Fule and Amin, 2014).

Stability Studies

The stability studies of the optimized fast-dissolving films were carried out under different conditions according to ICH guidelines. The film was packed in the aluminium foil and stored in a stability chamber for stability studies. Accelerated Stability studies were carried out at 40 0C / 75 % RH for 3 months and the patches were characterized for the drug content and other parameters during the stability study period.

RESULTS AND DISCUSSION

Preparation of Ropinirole Hydrochloride Films

It was aimed to prepare fast dissolving oral films of Ropinirole hydrochloride with the dose of 1 mg per 4 cm2 film. Total 27 formulations were prepared using different polymers and the resulting films were shown in Figure 1.


Fig. 1. Ropinirole hydrochloride films.

Physico Chemical Evaluation of Films

The results of the physical tests of the prepared blends were within the limits.

This is essential to ascertain uniformity in the thickness of the film as this is directly related to the accuracy of dose in the strip. Low SD values in the film thickness measurements ensured uniformity of thickness in each formulation. Differences in thickness of films may due to differences of viscosities of polymeric solutions. The average thickness of the formulation F1 to F27 ranged from 0.11 ± 0.13 to 0.15 ± 0.45 mm.

The Tensile Strength measures the ability of film to withstand rupture. It was found to be satisfactory. Tensile Strength of formulation PF1 to PF27 was found to have folding endurance in the range of 10.1 ± 0.36 to 16.0 ± 0.14.

The folding endurance measures the ability of film to withstand rupture. It was found to be satisfactory. Folding endurance of formulation F1 to F27 was found to have folding endurance in the range of 109 ± 1.43 to 120 ± 1.69.

Homogeneous uniform drug distribution is one of the important characteristic of a fast dissolving film that ensures the uniform reproducible release of the drug from the film. Drug content uniformity (%) of formulations F1 to F27 was in the range of 95.31 ± 0.24 to 99.23 ± 1.01. Estimation of drug content indicated that the drug is uniformly distributed throughout the films, evidenced by the low values of the SD. The surface pH of fast dissolving films was determined in order to investigate the possibility of any side effects in vivo. The surface pH of films was found to be in the range of 6.5 ± 0.051 to 6.9 ± 0.012. It assured that there will not be any kind of irritation to the mucosal lining of the oral cavity.

As expected increase in the polymer concentration increases disintegration time. While for a fixed polymer quantity, higher content resulted in faster disintegration of the films. Disintegration time (Sec) of the formulations F1 to F27 was found to be in the range of 11 ± 1.41 to 17 ± 1.45 (Table 2).

TABLE 2

Physico-chemical evaluation properties of FD Films of Ropinirole HCl.

F.NO Thickness (mm) Tensile Strength (gm/cm2) Folding Endurance Content uniformity (%) Surface pH DT (Sec)

F1 0.13 ± 0.04 11.7 ± 0.12 114 ± 1.13 96.13 ± 0.63 6.6 ± 0.037 13 ± 1.23 F2 0.12 ± 0.13 15.5 ± 0.26 113 ± 1.25 98.04 ± 0.06 6.8 ± 0.011 14 ± 1.51 F3 0.14 ± 0.35 13.9 ± 0.18 116 ± 1.11 97.56 ± 0.14 6.5 ± 0.039 16 ± 1.48 F4 0.11 ± 0.89 16.0 ± 0.14 120 ± 1.69 99.23 ± 1.01 6.9 ± 0.012 11 ± 1.41 F5 0.14 ± 0.22 12.0 ± 0.89 113 ± 1.15 96.69 ± 0.8 6.7 ± 0.017 13 ± 1.20 F6 0.12 ± 0.13 14.7 ± 0.16 114 ± 1.10 98.45 ± 0.31 6.5 ± 0.025 15 ± 1.85 F7 0.14 ± 0.63 12.1 ± 0.10 116 ± 1.16 95.11 ± 0.49 6.6 ± 0.045 14 ± 1.61 F8 0.14 ± 0.27 14.5 ± 0.40 109 ± 1.19 96.23 ± 0.51 6.7 ± 0.077 16 ± 1.37 F9 0.15 ± 0.18 11.1 ± 0.23 112 ± 1.21 95.15 ± 0.23 6.8 ± 0.002 13 ± 1.89

F10 0.13 ± 0.10 12.6 ± 0.42 115 ± 1.29 98.89 ± 0.47 6.6 ± 0.023 17 ± 1.24 F11 0.15 ± 0.17 12.5 ± 0.34 110 ± 1.43 95.47 ± 0.38 6.7 ± 0.017 14 ± 1.16 F12 0.14 ± 0.19 10.1 ± 0.78 115 ± 1.66 96.81 ± 0.22 6.5 ± 0.068 16 ± 1.45 F13 0.14 ± 0.12 14.5 ± 0.40 113 ± 1.27 98.45 ± 0.47 6.8 ± 0.089 14 ± 1.78 F14 0.15 ± 0.28 13.4 ± 0.22 116 ± 1.43 97.65 ± 0.11 6.5 ± 0.028 15 ± 1.85 F15 0.14 ± 0.58 11.9 ± 0.13 117 ± 1.69 97.57 ± 0.24 6.6 ± 0.048 17 ± 1.09 F16 0.11 ± 0.11 10.1 ± 0.36 112 ± 1.35 98.85 ± 0.39 6.5 ± 0.096 15 ± 1.89 F17 0.13 ± 0.10 12.5 ± 0.66 114 ± 1.38 95.56 ± 0.44 6.8 ± 0.029 14 ± 1.52 F18 0.15 ± 0.19 14.7 ± 0.15 115 ± 1.51 98.68 ± 0.47 6.8 ± 0.022 13 ± 1.19 F19 0.14 ± 0.13 14.9 ± 0.17 116 ± 1.13 96.34 ± 0.55 6.7 ± 0.019 16 ± 1.35 F20 0.11 ± 0.26 15.1 ± 0.34 115 ± 1.27 95.31 ± 0.24 6.7 ± 0.049 17 ± 139 F21 0.11 ± 0.37 11.2 ± 0.16 116 ± 1.45 98.23 ± 0.87 6.5 ± 0.041 16 ± 1.25 F22 0.13 ± 0.48 14.5 ± 0.40 117 ± 1.59 97.36 ± 0.61 6.8 ± 0.085 13 ± 1.69 F23 0.11 ± 0.57 10.7 ± 0.13 110 ± 1.49 95.45 ± 0.38 6.7 ± 0.062 17 ± 1.45 F24 0.13 ± 0.38 12.8 ± 0.10 116±1.23 97.29 ± 0.62 6.6 ± 0.046 14 ± 1.36 F25 0.15 ± 0.45 11.2 ± 0.33 119±1.48 98.36 ± 0.55 6.8 ± 0.014 13 ± 1.39 F26 0.12 ± 0.58 14.5 ± 0.25 116±1.51 96.38 ± 0.45 6.7 ± 0.025 14 ± 1.48 F27 0.14 ± 0.49 10.6 ± 0.38 116±1.33 96.89 ± 0.13 6.5 ± 0.051 15 ± 1.78

Values are expressed in mean ± SD: (n = 3)


In vitro Drug Release Profile of Fast Dissolving Films of Ropinirole HCl

Fig. 2. Cumulative % drug released of formulation of F1-F7.





Being the fast disintegrating formulations the release rates of all the formulations were very rapid. It was noticed that the films got hydrated rapidly and began to dissolute the drug within minutes. This may be due to the water solubility of the drug and the polymer. The water soluble filler sucralose was reported to be used as inert carrier to form a high water soluble dispersion with active agents. Films formed by higher quantity of polymer had shown slower dissolution rate this might be due to the increase level of polymer, results in formation of high viscosity gel layer caused by more intimate contact between the particles of polymer results in decreased mobility of drug particles in swollen matrices, which leads to decrease in release rate. From the In vitro drug release, it was observed that in formulation containing low concentration of polymer, the drug release was found to be faster and higher from films of F4 when compared with the other films, so F4 is considered as a optimized formulation based on in vitro release studies. The drug release from marketed product was found to be 92.77±1.52 after 50 min (Figure 2, 3, 4 & 5).

Design of Experiment

This method is mainly used to explain the effect of one factor on other. To know whether this effect is significant or not, if significant how it influences the response. In present work the effect of one factor (PEG 4000) on other two factors (HPMC E 15, Maltodextrin) is explained (Figure 6, 7 & 8).

In the above graph, the effect of PEG 4000 on percentage cumulative drug release was examined and it clearly indicates that there is a very significant effect of PEG 4000 on percentage cumulative drug release. From the in vitro drug release study observed that as concentration of polymer increase, % drug release was decreased and as the concentration of plasticizer increase, % drug release was increased. However, prediction of results of percentage drug release, response surface plot was plotted for graphical representation of results. Therefore, figure showed common effect of plasticizer and polymer concentration. We can conclude from the contour plot for formulation batch F1 to F27

that, percentage drug release was decreased as the concentration of polymer increased and percentage drug release was increased as the plasticizer concentration increased.

There is a negligible effect on tensile strength of formulations because both the polymers in formulations have excellent tensile strength and there is slightly influence on tensile strength by PEG 4000.

Disintegration Time observed that as concentration of polymer increase, disintegration time was decreased and as the concentration of plasticizer increase, disinter-gration time was increased.

Drug Excipient Compatability Studies

Fourier Transform Infrared Spectroscopy (FTIR) The major peaks obtained in the FT-IR studies of

pure drug Ropinirole hydrochloride like –NH, -C=O, -C=C stretching’s were remained unchanged when mixed with the polymers and in the formulation.

Overall there was no alteration in peaks of Ropinirole pure drug (Figure 9) and optimized formulation (Figure 10), suggesting that there was no interaction between drug and excipients. There is additional peaks appeared or disappeared hence no significant changes in peaks of optimized formulation was observed when compared to pure drug indicating absence of any interaction

SEM studies: SEM of Ropinirole hydrochloride oral dissolving film shows the rough and uneven surface with circular pits with the absence of particles suggesting the presence of the drug in dissolved state in the polymer HPMC. They further ensure the loss of crystallinity when formulated as a film comprising amorphous HPMC (Figure 11).

Stability study: There were no physical changes in appearance and flexibility. After subjecting the optimized formulation (F4) to the Accelerated Stability Studies, the results were shown that there were no major changes in drug content, in itro drug release, tensile strength and disintegration time. Hence, this formulation was found to be stable.


Fig. 6. Response surface plot showing the influence of amount of polymer & Plasticizer on the release profile of Ropinirole HCl for percentage Cumulative Drug Release.

Fig. 7. Response surface plot showing the influence of amount of polymer & Plasticizer on tensile strength of Ropinirole HCl.

Fig. 8. Response surface plot showing the influence of amount of polymer & Plasticizer on Disintegration Time of Ropinirole HCl.


Fig. 9. FT-IR spectra of Ropinirole hydrochloride pure drug.

Fig. 10. FT-IR spectra Ropinirole optimized formulation (F4).

Fig. 11. Scanning electron micrograph of Palonosetron optimized oral dissolving films.

TABLE 3

Parameters after Accelerated Stability Study of Formulation F4.

Parameters Temperature Maintained at 40 ± 2 oC;

Relative Humidity (RH) Maintained at 75% ± 5% RH

Initial After 1 month After 2 months After 3 months

Drug Content (%) 99.23 ± 1.01 99.10 ± 1.12 98.71 ± 1.52 98.69 ± 1.10 In Vitro Drug Release (%) 99.68 ± 1.32 99.15 ± 1.18 98.71 ± 1.23 98.48 ± 1.18 Tensile Strength 16.0 ± 0.14 15.7 ± 0.11 15.4 ± 0.35 15.0 ± 0.85 Disintegration Time 19 ± 1.11 19 ± 1.03 18 ± 1.23 18 ± 1.01


Conclusions In the present investigation, an attempt was made to

formulate and evaluate twenty seven formulations (F1-F27) of ropinirole HCl oral dissolving films by solvent-casting method using 33 response surface method where 33 indicates 3 variables and 3 levels of polymers (HPMC E15, Maltodextrin) of different grades and plasticizer (PEG 4000) (low, middle and high concentrations) by using design of experiment software.

Formulations were evaluated for their physical characteristics, thickness, folding endurance, tensile strength, disintegration time, drug content uniformity and drug release characteristics and found to be within the limits. Among the prepared formulations F4 showed minimum disintegration time 11 sec, maximum drug was released i.e. 99.68±1.52% of drug within 10 min when compared to the other formulations and finalized as optimized formulation. FTIR and SEM data revealed that no interactions takes place between the drug and polymers used in the optimized formulation. The in vitro dissolution profiles of marketed product and optimized formulation was compared and found to be the drug released was 92.77 ± 1.52 after 50 min. Therefore it can be a good alternative to conventional Ropinirole HCl for immediate action. In vitro evaluation of the Ropinirole HCl fast dissolving films confirmed their potential as an innovative dosage form to improve delivery and quick onset of action of Ropinirole HCl. Therefore, the oral fast dissolving film is considered to be potentially useful for the treatment of Parkinson’s disease where the quick onset of action is desired, also improved patient compliance.

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Address correspondence to: D.V. R. N. Bhikshapathi, Professor & Head, Vijaya College of Pharmacy, Hayathnagar (M), Hyderabad-501511. Telangana, India. Mob: +91-9848514228; E-mail: [email protected]

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