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Patil, Shitalkumar S.
- Design, Development and Evaluation of Fast Dissolving Tablet of Antiasthmatic Drug
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Authors
Nikhil A. Patil
1,
Sandip A. Bandgar
1,
Sardar S. Shelake
1,
Pravin S. Patil
1,
Shitalkumar S. Patil
1
Affiliations
1 Ashokrao Mane College of Pharmacy, Dept. of Pharmaceutics, Peth Vadgaon, 416112, Kolhapur, Maharashtra, IN
1 Ashokrao Mane College of Pharmacy, Dept. of Pharmaceutics, Peth Vadgaon, 416112, Kolhapur, Maharashtra, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 1 (2019), Pagination: 142-148Abstract
The aim of the work is an attempt to design, development and evaluation of fast dissolving tablets of Levosalbutamol sulphate by direct compression method with the aid of superdisintegrant addition. Levosalbutamol (LS) is the R – enantiomer of short acting beta2 adrenergic receptor agonist of salbutamol used to treat asthma and Chronic obstructive pulmonary disease. Nine formulations were prepared by using three different superdisintegrants in varying concentration in such way that total weight of the tablet remains same. The drug-polymer incompatibility was analysed by FTIR studies. All the formulated tablets were subjected for pre and post-compression evaluation parameters. From the FTIR studies the drug-polymer compatibility were confirmed. The pre-compression parameters like bulk density, tapped density, Carr’s index and angle of repose was determined. The optimized formulation showed acceptable flow properties. The post-compression parameters like the thickness, hardness, friability and in vitro dispersion time, wetting time, water absorption ratio and in- vitro drug release were carried out and the values were found to be within IP limits. Among the nine formulations, the formulation containing Kyron T 314 (F9) showed highest drug release of 97.71 % than other formulations.Keywords
Levosalbutamol Sulphate, Fast Dissolving Tablet, Direct Compression, Superdisintegrants.
References
- Bhandari S, Mittapalli RK.. Orodisprsible tablet: An overview. Asian Journal of Pharmaceutics. 2008: 2-11.
- Velmuragan S, Vinushitha S. Oral Disintegreating Tablets: An Overview. International Journal of Chemical and Pharmaceutical Science. 1(2);2010:1-6.
- Jagani H, Patel R. Fast Dissolving Tablets. Journal of Advances in Pharmacy and Health Research. 2011; 2(1): 57-70.
- Saroha K, Mathur P. Mouth Dissolving Tablets: An Overview on Future Compaction Oral Formulation Technologies. Pelagia Research Library. 1(1);2010: 179-187.
- Siddiqui A, Garg G. Fast Dissolving Tablets: Preparation, Characterization and Evaluation: An Overview. International Journal of Pharmaceutical Sciences Review and research. 4(2); 2010: 87-96.
- Shelake S, Patil S, Patil S, Sangave S. Formulation and evaluation of fenofibrate-loaded nanoparticles by precipitation method. Indian J Pharm Sci. 80(3); 2018: 420-427.
- Bandgar S. A , Shelake S. S., Patil S. S. Solubility enhancement of poorly soluble drug by Various techniques. World Journal of Pharmacy and Pharmaceutical sciences. 6(9); 2017: 1405-1416.
- Shelake S, Mhetre R, Patil S, Patil S, Khade V. Formulation and evaluation of Microspheres for nasal delivery of antihypertensive drug. Indian J Pharm Sci. 80(3);2018:420-427.
- Prajapati BJ, Patel B. Formulation, Evaluation and Optimization of Oraly Disintigrating Tablet Piroxicam. International Journal of Pharma Tech Reseach. 2(3); 2010:1893-1899.
- Bangale GS, Yadhav GJ. New Generation of Orodispersible Tablets: Resent Advances and Future Prospect. International Journal Of Pharmacy And Pharmaceutical Science Research. 1(2);2011:52-62.
- Agrawal VA, Rajurkar RM. Fast disintegrating Tablet as a New Drug Delivery: A Review. Pharmacophore. 2(1); 2011:1-8.
- Raut Indrayani D., Bandgar Sandip A., Shah R. R., Chougule D.D. Formulation and Evaluation of Gastric Floating Tablet of Domperidone. Asian J. Res. Pharm. Sci. 4(1); 2014: 22-25.
- Bandgar S. A. , Yadav A. V., Patil S. S. Formulation and Evaluation of Cefetamet Pivoxil Hydrochloride Dispersible Tablet by Using Taste Masking (Particle Coating) Approach. Journal of Pharmacy Research. 2(11); 2009:1789-1793.
- Raut Indrayani D, Gharge Manisha, Dandwde Sonli, Mohite S.K., Magdum C.S. Formulation and Characterization of fast Dissolving tablets of Perindopril. Asian Journal of Pharmacy and Technology. 7(1); 2017: 51-55.
- Shelake S., Khade V., Sangave P, Patil S. Development and Evaluation of Colon Specific Drug Delivery System via pH and Microbial Triggered Mechanism for Colon Cancer. American Journal of Pharmaceutical Research. 7(5); 2017: 218-228.
- Bhati S, Sethi V. Formulation and evaluation of fast dissolving tablets of metoclopramide hydrochloride using natural sweetening agent of stevia leaf powder. Int. J. Res. Dev. Pharm. L. Sci. 3(1);2013:833-838.
- Dekivadia M, Gudigennavar A, Patil C, Umarji B. Development and optimization of fast Dissolving tablet of levocetirizine HCL. International Journal of Drug Development and Research.4(2);2012:237-246.
- Stability Indicating Forced Degradation Studies
Abstract Views :165 |
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Authors
Affiliations
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 1 (2019), Pagination: 429-433Abstract
Forced degradation study (FD) studies (stress testing) are an intrinsic part of pharmaceutical product development. It is procedure whereby the natural degradation rate of a product or material is increased by the application of additional stress condition. It manifests chemical behaviour of the molecule which helps in the development of formulation and packaging of pharmaceutical development. It is necessary to specify the specificity of the stability indication methods and provide insight into degradation pathways and degradation products of the drug substance and aid in an elucidation of the structure of the degradation products. This review discusses the regulatory aspects of force degradation and the study of stability and also the analytical hyphenated methods used for the development of the forced degradation study.Keywords
Forced Degradation, Regulatory Aspects, Degradation Products.References
- ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision2), International Conference on Harmonization.
- FDA Guidance for Industry, INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology Derived Products, Draft Guidance, Food and Drug Administration.
- Alsante KM, Hatajik TD, Lohr LL, Santafianos D Sharp TR. Solving impurity/degradation problems: case studies. pp: 380, In; handbook of Isolation and Characterization of impurities in Pharmaceutical, Ahuja S, Alsante K, editors, Academics Press, New York. 2003.
- Boccardi G. Oxidative susceptibility testing,:220. In; pharmaceutical Stress Testing-Predicting Drug Degradation; Baertschi SW, editors, Taylor and Francis, New York. 2005.
- Alan RO, Brigitte ES, Yanqiu SA, Polshyna NM, Dunphy R, Barbara LM, et al. Forced degradation studies of rapamycin: Identification of autoxidation products. J Pharmaceut Biomed 59, 2012: 194-200.
- Trabelsi H, Hassen IE, Bouabdallah S, Bouzouita K, Safta F. Stability indicating LC method for determination of Pipamperone. J Pharmaceut Biomed 39, 2005: 914-919.
- Dorman DE, Lornez LJ, Occolowitz JL, Spangle LA, Collins, MW, Bashore FN, Baertschi SW. Isolation and structure elucidation of the major degaradtion products of cefaclor in the solid state. J Pharm. Sci 86, 1997: 526-539.
- Bojana P, Markus D, Kappe CO. Microwave-assisted forced degradation using high-throughput microtiter platforms. J Pharmaceut Biomed 56, 2011:867-873.
- Baertschi SW, Thatcher SR. Sample presentation for photostability studies: problems and solutions, pp: 445, In; Pharmaceutical Photostability and Stabilization Technology. Piechocki J, Editor, Taylor & Francis, New York. 2006.
- Baertschi SW, Alsante KM. Stress testing: the chemistry of the drug degradation, pp: 99, In Pharmaceutical Stress Testing, Baertschi SW, editors, Taylor & Francis, New York. 2005.
- D.W. Reynolds, K.L.Facchine, J.F. Mullaney, et al., Available guidance and best practices for conducting forced degradation studies, Pharm. Technol. 26(2), (2002): 48–56.
- Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Phrama Tech. 24, 2000: 1-14.
- H. Brummer, How to approach a forced degradation study, Life Sci. Technol. Bull.31, (2011):1–4.
- Blessy M., Ruchi D.Patel,Prajesh M. Prajapati, Y.K.Agarwal. Development of Forced degradation and stability indicating studies of drugs-A Review.Journal of Pharmaceutical Analysis.4 (3); 2014:159-165.
- Smita Shinde.S.A.Nirmal .A Review on Force Degradation Study for Pharmaceutical Product Development. International journal of Pharmaceutical and chemical sciences .5(2), 2016: 163-166.
- A Review:Stability Indicating Forced Degradation Studies
Abstract Views :156 |
PDF Views:0
Authors
Affiliations
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
1 Ashokrao Mane College of Pharmacy, Peth-Vadgaon, Maharashtra, 416112, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 2 (2019), Pagination: 885-890Abstract
Forced degradation study (FD) studies (stress testing) are an intrinsic part of pharmaceutical product development. It is procedure whereby the natural degradation rate of a product or material is increased by the application of additional stress condition. It manifests chemical behaviour of the molecule which helps in the development of formulation and packaging of pharmaceutical development. It is necessary to specify the specificity of the stability indication methods and provide insight into degradation pathways and degradation products of the drug substance and aid in an elucidation of the structure of the degradation products. This review discusses the regulatory aspects of force degradation and the study of stability and also the analytical hyphenated methods used for the development of the forced degradation study.Keywords
Forced Degradation, Regulatory Aspects, Degradation Products.References
- ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision2), International Conference on Harmonization.
- FDA Guidance for Industry, INDs for Phase 2 and 3 Studies of Drugs, Including Specified Therapeutic Biotechnology Derived Products, Draft Guidance, Food and Drug Administration.
- Alsante KM, Hatajik TD, Lohr LL, Santafianos D Sharp TR. Solving impurity/degradation problems: case studies. pp: 380, In; handbook of Isolation and Characterization of impurities in Pharmaceutical, Ahuja S, Alsante K, editors, Academics Press, New York. 2003.
- Boccardi G. Oxidative susceptibility testing,:220. In; pharmaceutical Stress Testing-Predicting Drug Degradation; Baertschi SW, editors, Taylor and Francis, New York. 2005.
- Alan RO, Brigitte ES, Yanqiu SA, Polshyna NM, Dunphy R, Barbara LM, et al. Forced degradation studies of rapamycin: Identification of autoxidation products. J Pharmaceut Biomed 59;2012: 194-200.
- Trabelsi H, Hassen IE, Bouabdallah S, Bouzouita K, Safta F. Stability indicating LC method for determination of Pipamperone. J Pharmaceut Biomed 39;2005: 914-919.
- Dorman DE, Lornez LJ, Occolowitz JL, Spangle LA, Collins, MW, Bashore FN, Baertschi SW. Isolation and structure elucidation of the major degaradtion products of cefaclor in the solid state. J Pharm. Sci 86;1997: 526-539.
- Bojana P, Markus D, Kappe CO. Microwave-assisted forced degradation using high-throughput microtiter platforms. J Pharmaceut Biomed 56;2011:867-873.
- Baertschi SW, Thatcher SR. Sample presentation for photostability studies: problems and solutions, pp: 445, In; Pharmaceutical Photostability and Stabilization Technology. Piechocki J, Editor, Taylor & Francis, New York. 2006.
- Baertschi SW, Alsante KM. Stress testing: the chemistry of the drug degradation, pp: 99, In Pharmaceutical Stress Testing, Baertschi SW, editors, Taylor & Francis, New York. 2005.
- D.W. Reynolds, K.L.Facchine, J.F. Mullaney, et al., Available guidance and best practices for conducting forced degradation studies, Pharm. Technol.26(2);(2002):48–56.
- Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Phrama Tech. 24; 2000: 1-14.
- H. Brummer, How to approach a forced degradation study, Life Sci. Technol. Bull.31; (2011):1–4.
- Blessy M., Ruchi D.Patel,Prajesh M. Prajapati, Y.K.Agarwal. Development of Forced degradation and stability indicating studies of drugs-A Review.Journal of Pharmaceutical Analysis.4 (3); 2014:159-165.
- Smita Shinde.S.A.Nirmal .A Review on Force Degradation Study for Pharmaceutical Product Development. International journal of Pharmaceutical and chemical sciences .5(2); 2016: 163-166.