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Development and Evaluation of a Buccal Bioadhesive System for Smoking Cessation Therapy

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Development and Evaluation of a Buccal Bioadhesive System for Smoking Cessation Therapy ORIGINAL ARTICLES National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab, India Development and evaluation of a buccal bioadhesive system for smoking cessation therapy S. Garg, G. Kumar Received July 17, 2006, accepted August 13, 2006 Sanjay Garg, School of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Privat Bag 92-019, Auckland, New Zealand [email protected] Pharmazie 62: 266–272 (2007) doi: 10.1691/ph.2007.4.6144 The objective of the present study was to develop a bilayered buccal bioadhesive film formulation of nicotine hydrogen tartrate for smoking cessation therapy, comprising a bioadhesive drug layer and a backing layer, which releases the drug at a pre-determined rate for a period of 4 h. Formulations were prepared using various bioadhesive polymers and were evaluated for physical parameters like peelability, flexibility, softness, bioadhesive strength, tensile strength, dispersion time and pharmaceu- tical parameters such as thickness, swelling, content uniformity, water vapour permeability and drug release. Based on these parameters formulation N2, containing hydroxypropyl methylcellulose and polycarbophil as the bioadhesive polymers, was selected as the optimized formulation. The formula- tion showed suitable adhesion and an initial burst release of 40% drug in first 15 min followed by a total 80% drug release in a characteristic manner until 4 h; which is the desired time of application. This release pattern is beneficial for patients suffering from emergent cravings. Backing layers of the films were studied by a moisture vapor permeability test and it was observed that the percentage of moisture which permeated through single layered films was much higher than through bilayered films implying that a backing layer would prevent washing out of drug by the saliva. 1. Introduction forms leads to inefficient treatment (deVries et al. 1991; Gupta et al. 1992; Smart 1993). Subsequently, bioadhesive Smoking is the single most common cause of morbidity formulations can serve a potential solution to the problem and mortality worldwide (Panchagnula et al. 2000). An- with localized delivery, prolonged residence time and re- nually, over 30% of the approximately 50 million US adults duced dosing frequency (deVries et al. 1991; Hao and Heng who smoke daily make a serious attempt to quit smoking, 2003; Nafee et al. 2004). Amongst the bioadhesive formu- but only 2–5% of them are able to quit permanently (Wood lations, films offer various advantages such as low dose, 1995; Sweeney et al. 2001; Corelli and Hudmon 2002). flexibility in shape and size and drug delivery at a pre- US FDA has approved sustained release bupropion and determined rate for local or systemic effects (Bhaichwal four nicotine replacement products: nicotine gum, trans- 1985; Bruschi and de Freitas 2005). dermal nicotine patch, nicotine nasal spray, and nicotine The objective of the present study was to develop and vapour inhaler (Wood 1995; Sweeney et al. 2001; Corelli evaluate a bilayered buccal bioadhesive film formulation and Hudmon 2002; Rigotti 2002). Nicotine Replacement of nicotine hydrogen tartrate consisting of a bioadhesive Therapy (NRT) is the most widely used therapy for smok- drug layer and a backing layer for smoking cessation ther- ing cessation and comprises a combination of medications apy. The formulation was evaluated for various physical with passive (transdermal patch) and instantaneous nico- and pharmaceutical parameters and accelerated stability tine delivery (e.g. gum, nasal spray, inhaler) with the ratio- studies were conducted on the optimized formulation. nale of providing a slow and steady supply of nicotine to achieve constant concentration levels to relieve craving and withdrawal symptoms. There has been ongoing re- 2. Investigations and results search on various oral NRT products including biphasic buccal adhesive tablets and bioadhesive buccal tablets The physical parameters evaluated for placebo films and (Park and Munday 2002; Ikinci et al. 2004, 2006; Park drug containing films are reported in Tables 1 and 2. and Munday 2004). Swelling property plays an important role in the bioadhe- The buccal route of drug administration offers easy acces- sive strength and drug release kinetics of the films. The sibility to systemic circulation for drugs with low bioavail- bioadhesive capacity primarily depends on the concentra- ability and thus bypasses the first pass effect. However, tion and swelling behaviour of the polymer in the aqueous limitations associated with this route like smaller surface environment. Swelling capacity of the polymers was stu- areas available and limited retention capacity of dosage died using a 1.4% agar gel as discussed in section 4.5.2. 266 Pharmazie 62 (2007) 4 ORIGINAL ARTICLES Table 1: Evaluation of placebo films Batch Peelabilitya Softnessa Flexibilitya Appearance Thicknessb (mm) Dispersion Timec (min) P1 *** ** ** Transparent 0.18 Æ 0.02 18 P2 *** * ** Transparent 0.28 Æ 0.02 17 P3 *** * * Transparent 0.30 Æ 0.05 15 P4 ** ** ** Transparent 0.14 Æ 0.02 15 P5 *** ** *** Translucent 0.14 Æ 0.02 20 P6 ** * * Polymer precipitation 0.38 Æ 0.08 35 P7 ** ** ** Transparent 0.33 Æ 0.08 20 P8 ** *** *** Transparent 0.30 Æ 0.05 7.3 P9 ** *** *** Transparent 0.06 Æ 0.01 4.5 P10 *** ** ** Transparent 0.14 Æ 0.02 360 a * Average, ** Good, *** Excellent b Values expressed as mean Æ Standard Deviation (S.D.), n ¼ 5 c Dispersion time was determined from time taken for complete dissolution of bioadhesive layer of film in 10 ml of simulated saliva solution maintained at 37 C Table 2: Evaluation of buccal bioadhesive films Batch Peelabilitya Appearance Flexibilitya Thickness (mm)b Bioadhesive strength (N)b Tensile strength (N)b N1 *** Precipitation of drug on surface *** 0.19 Æ 0.02 –––– N2 *** Translucent *** 0.036 Æ 0.05 5.94 Æ 0.66 94.08 Æ 7.06 N3 N Precipitation of drug and polymer –––––––– a * Average, ** Good, ***Excellent, N Non peelable b Values expressed as mean Æ Standard Deviation (S.D.), n ¼ 5 A plot of percentage hydration of N2 films versus time is Percentage moisture permeated through N2 films vs time shown in Fig. 1. The percentage hydration of N2 films is shown in Fig. 3. showed a direct relationship with time. All films were in- The thickness of a buccal film should be optimum. It tact after completion of swelling studies. should not be too thick to be felt in the mouth or too thin Bioadhesive strength is a major tool to ascertain the bioad- hesive capacity of a polymer in bioadhesive buccal drug delivery systems. The average values of bioadhesive 90 7 strength and tensile strength of N2 films (n ¼ 5) was found 6 to be 5.94 (Æ0.66) N and 94.08 (Æ7.06) N (Table 2). Also, 80 tensile strength properties are extremely important for any 5 Release rate (mg/hr) film formulation as they ensure the strength of the film, its 70 4 behaviour during handling, application and use. The re- sults of tensile strength revealed that N2 film requires a 60 3 force of 94 N to break the film (Table 2). % Drug Release The release profile of N films is shown in Fig. 2. Up to 2 2 50 80% of the drug is released in a sustained manner for 4 h. 1 An initial unexpected drug release of 40% in less than 40 0 15 min was observed followed by a sustained release until 0 1 2 3 4 5 6 7 the end of 4 h. Time (hours) The content uniformity of N2 films (n ¼ 3) was deter- % Drug release vs. Time mined using an in house HPLC method. The mean per- Release rate centage recovery of drug was 93.18 (Æ4.46)%. Fig. 2: Percent drug release time and release rate profiles of N2 films [each time point represents mean Æ S.D. (n ¼ 3)] 180 0.10 0.09 160 0.08 BF 0.07 DF 140 0.06 0.05 120 0.04 % Hydration 0.03 0.02 100 Moisture permeation (%) 0.01 0.00 80 0 50 100 150 200 250 0 100 200 300 Time (min) Time (min) Fig. 3: Percent moisture permeation through BF (Bilayered films) and DF Fig. 1: Swelling behaviour of N2 buccal bioadhesive film (n ¼ 3, mean Æ (Drug containing bioadhesive layer without backing layer) of N2 S.D.) films [each time point represents mean Æ S.D. (n ¼ 3)] Pharmazie 62 (2007) 4 267 ORIGINAL ARTICLES Table 3: Evaluation of backing layer Batch Peelabilitya Softnessa Flexibilitya Appearance Thicknessb (mm) B1 N–––––––– B2 N–––––––– B3 ** ** ** Translucent 0.28 Æ 0.05 B4 *** *** *** Transparent but striations 0.22 Æ 0.02 B5 *** * ** Transparent but air bubbles 0.23 Æ 0.03 B6 N–––––––– B7 ** ** * Striations on surface 0.23 Æ 0.04 B8 ** ** ** Polymer precipitation 0.21 Æ 0.02 a * Average, ** Good, *** Excellent, N Not peelable b Values expressed as mean Æ Standard Deviation (S.D.), n ¼ 5 Table 4: Stability studies of buccal bioadhesive film N2 Time points Thickness (mm)a Weight uniformityb (mg) Bioadhesive strengthc (N) Tensile strengthc (N) Initial 0.523 Æ 0.03 226.9 Æ 12.15 5.343 Æ 1.408 121.52 Æ 13.41 15 days 0.575 Æ 0.05 237.3 Æ 12.94 6.0 Æ 0.59 128.9 Æ 17.57 a Thickness of stability samples (n ¼ 10) was measured by digital thickness gauge b Values expressed as mean Æ Standard Deviation (S.D.), n ¼ 10 c Values expressed as mean Æ Standard Deviation (S.D.), n ¼ 5 to create problems during handling or dissolve quickly. od of study, so as to retain the formulation until that time. Also, variation in thickness would lead to non-uniformity Initially, HPMC was selected as the bioadhesive polymer in drug content and subsequently alter the drug release which has good water absorbing capacity and slow ero- and kinetics of drug release (Peh and Wong 1999; Sharma sion property.
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