The availability of directly compressible co-processed gum material enables rapid, safe and low-cost development of MCG as a drug delivery option. By MCG formulation, revitalization of old products and reformulation of new patented products is possible, to differentiate them from upcoming generics competition in the market.
Introduction:Common cold is the most frequently recurring disease in the world and is a leading cause of doctor visits and missed days from school and work. Cold reliever medicated chewing gum (MCG) will be a definitive patient acceptable solution for this condition. Anti-allergic, cetirizine (CTZ) is a BCS class-I (highly soluble and highly permeable) non-sedating antihistaminic drug and this study was based on the hypothesis that CTZ as a BCS class I drug will be easily released from chewing gum into the salivary fluid within few minutes of chewing and can be easily permeated from oral mucosa by the pressure created by the chewing action and absorbed to a larger extent into the systemic circulation. Therefore, ultimately patients will get quick relief from symptoms of common cold with greater compliance compared to other conventional dosage forms.Materials and Methods:This study mainly focuses on taste masking of CTZ by inclusion complexation method, its formulation development in the MCG form and its quality and performance evaluation with the study of potential factors affecting drug release by 32 full factorial experimental design. A “chew out” study is carried out to assess in vivo drug release from MCG, in which residual amount is extracted from the chewed sample.Results:Formulation ingredients, such as elastomers, softeners, bulking agents, play an important role in the feel of the final product and its consistency; while sweeteners and flavors play a very essential character in its sensory properties.Conclusion:Interindividual variation in chewing frequency and chewing intensity is the main factor which affects release of active ingredient from MCG; while salivary dilution and involuntary swallowing are main reasons for variability in the absorption site, i.e., either from buccal mucosa or from gastrointestinal tract.
Background:Lacidipine (LCDP) is a 1,4-dihydropyridine derivative categorized as an anti-hypertensive Ca2+ channel blocker having very low solubility, and thus very low oral bioavailability, which presents a challenge to the formulation scientists. Homogeneous distribution of poorly water-soluble drugs like LCDP in polyvinylpyrrolidone (PVP), a hydrophilic carrier, is definitely a suitable way to improve the bioavailability of such drugs.Materials and Methods:The aim of the study was to develop a combined thermal, imaging, and spectroscopic approach, and characterize physical state, dissolution behavior, and elucidation of drug–PVP interaction in LCDP/PVP solid dispersion (SD) using differential scanning calorimetry (DSC), X-ray diffractometry (XRD), fourier transform infrared (FTIR) spectroscopy, and hot stage microscopy (HSM), which is the prerequisite for the development of a useful drug product.Results:Dissolution studies of LCDP and its physical mixture with PVP showed less than 50% release even after 60 min, whereas SD of LCDP/PVP ratio of 1:10% w/w showed complete dissolution within 45 min. DSC and powder XRD proved the absence of crystallinity in LCDP/PVP SD at a ratio of 1:10% w/w. The FTIR spectroscopy indicated formation of hydrogen bond between LCDP and PVP. In the SD FTIR spectra, the –NH stretching vibrations and the –C=O stretch in esteric groups of LCDP shift to free –NH and C=O regions, indicating the rupture of intermolecular hydrogen bond in the crystalline structure of LCDP.Conclusion:Solid-state characterization by HSM, DSC, XRD, and FTIR studies, in comparison with corresponding physical mixtures, revealed the changes in solid state during the formation of dispersion and justified the formation of high-energy amorphous phase.
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