Polymorphic screen and drug–excipient compatibility studies of the antichagasic benznidazole

2011 ◽  
Vol 106 (3) ◽  
pp. 819-824 ◽  
Author(s):  
Flávia Pires Maximiano ◽  
Kátia Monteiro Novack ◽  
Maria Terezinha Bahia ◽  
Lívia Lira de Sá-Barreto ◽  
Marcílio Sérgio Soares da Cunha-Filho
Keyword(s):  
Compatibility Studies ◽  
Excipient Compatibility

Fluconazole–excipient compatibility studies as the first step in the development of a formulation candidate for biowaiver

2014 ◽  
Vol 120 (1) ◽  
pp. 771-781 ◽  
Author(s):  
Lilian Klein Teleginski ◽  
Aline Biggi Maciel ◽  
Cassiana Mendes ◽  
Marcos Antônio Segatto Silva ◽  
Larissa Sakis Bernardi ◽  
...  
Keyword(s):  
Compatibility Studies ◽  
Excipient Compatibility

scholarly journals Formulation and Invitro evaluation of immediate release tablets containing febuxostat

2021 ◽  
pp. 93-101
Author(s):  
Srikumar Billa ◽  
Saibabu Ch ◽  
Malyadri T
Keyword(s):  
Research Work ◽  
Immediate Release ◽  
Direct Compression ◽  
Compatibility Studies ◽  
Compression Method ◽  
First Order ◽  
First Order Kinetics ◽  
Croscarmellose Sodium ◽  
Physical Changes ◽  
Excipient Compatibility

In the present research work, Febuxostat Immediate Release Tablet was prepared by direct compression method using varying concentrations of Lycoat, Crospovidone& Croscarmellose sodium as disintegrants. The formulations prepared were evaluated for precompression& post-compression parameters. From the drug excipient compatibility studies, we observe that there are no interactions between the pure drug (Febuxostat) and optimized formulation (Febuxostat+ excipients) which indicates there are no physical changes. Post compression parameters were found to be within the limits. Among the formulation prepared the tablet containing 12mg of CCS shows 98.13% of the drug release within 45 min & follows first-order kinetics.

scholarly journals DEVELOPMENT AND VALIDATION OF REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR GABAPENTIN AND ITS RELATED SUBSTANCES IN CAPSULE DOSAGE FORM AND EXCIPIENT COMPATIBILITY STUDIES

2018 ◽  
Vol 11 ◽  
Author(s):  
Afroz Patan
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Reversed Phase ◽  
Hplc Method ◽  
Compatibility Studies ◽  
Compound A ◽  
Related Substances ◽  
Rp Hplc ◽  
Excipient Compatibility

Objective: A simple, accurate, precise, and reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for gabapentin (GBP) and its related substances in the capsule dosage form and excipient compatibility studies. Methods: The review of literature indicates that various methods have been reported for the estimation of GBP. When some excipients were used for GBP, it produced degradation product called lactam due to the presence of more water content. Hence, a novel RP-HPLC method has been developed for studying excipient compatibility and related substances of GBP in capsule dosage form using excipients such as lactose anhydrous and dried maize starch which is having less water activity. Waters Alliance e2695 separation module with ultraviolet/photodiode array (UV/PDA) detector with Inertsil C8 (250 mm×4.6 mm); 5 μm with an injection volume of 50 μl is injected and eluted with the (gradient program) mobile Phase A buffer: acetonitrile (940:60) and mobile phase B buffer: acetonitrile (700:300) pH 6.9 with 5 N potassium hydroxide which is pumped at a speed of 1.5 ml/min and detected by UV/PDA detector at 210 nm. The peaks of GBP and GBP-related compound A are well separated at 6.7 min and 34.5 min, respectively. Results: The method developed was approved for various parameters such as accuracy, specificity, precision, intermediate precision, range, linearity, robustness, limit of detection, limit of quantification, steadiness, and system suitability according to the International Conference on Harmonization guidelines. The results got were according to the acceptance criteria. Conclusion: The technique proposed was assured for detection of related substances in the marketed formulation and could be used for the routine analysis of GBP and GBP-related compound A in the capsule dosage form.

scholarly journals FORMULATION AND EVALUATION OF STATISTICALLY DESIGNED IBUPROFEN FASTDISSOLVING TABLETS EMPLOYING STARCH GLUTAMATE AS A NOVEL SUPERDISINTEGRANT

2019 ◽  
pp. 85-94
Author(s):  
SANTOSH KUMAR R ◽  
SAHITHI MUDILI
Keyword(s):  
Peak Plasma ◽  
Potato Starch ◽  
Peak Plasma Concentration ◽  
Drug Dissolution ◽  
In Vitro Dissolution ◽  
Pharmacokinetic Studies ◽  
Compatibility Studies ◽  
Short Period ◽  
Excipient Compatibility

Objective: The main aim of the present work is to enhance the solubility and bioavailability of the ibuprofen by formulating it into fast-dissolving tablets employing starch glutamate as a novel superdisintegrant. Materials and Methods: Starch glutamate was prepared from native potato starch and glutamic acid by the esterification process. Drug-excipient compatibility studies were performed between the starch glutamate and ibuprofen with the help of Fourier transform infrared spectroscopy, and differential scanning calorimetry techniques. Ibuprofen fast dissolving tablets were formulated employing different superdisintegrants along with the starch glutamate (a novel superdisintegrant) by the direct compression method. The prepared ibuprofen fast-dissolving tablets were evaluated for various pre- and post-compression parameters along with the in vitro and in vivo release characteristics. Optimized formulation stability studies were performed at accelerated conditions for 6 months as per the International Conference on Harmonization (ICH) and WHO guidelines. Results: Drug-excipient compatibility studies indicated that prepared starch glutamate was compatible with ibuprofen drug, and it can be used as a superdisintegrant in the formulation of fast-dissolving tablets. Fast-dissolving tablets of ibuprofen were formulated by employing starch glutamate as a superdisintegrant showed good tablet properties and showed an increased dissolution efficiency of the drug. Among all the formulations (F1–F8), the formulation F4 which contains 5% starch glutamate and 5% croscarmellose sodium as superdisintegrants showed 99.7±0.34% drug dissolution within 5 min. Peak plasma concentration of optimized formulation F2 was achieved in a short period of time and increased relative bioavailability and F2 was found to be stable during accelerated stability testing as per the ICH stability guidelines. Conclusion: From drug-excipient compatibility studies, disintegration time, in vitro dissolution studies, and pharmacokinetic studies, it was concluded that starch glutamate can be used as a superdisintegrant in the formulation of fast-dissolving tablets to increase the solubility as well as bioavailability of the poorly soluble drugs.

Drug-excipient compatibility studies in binary and ternary mixtures by physico-chemical techniques

2009 ◽  
Vol 102 (1) ◽  
pp. 193-201 ◽  
Author(s):  
Giovanna Bruni ◽  
Vittorio Berbenni ◽  
Chiara Milanese ◽  
Alessandro Girella ◽  
Amedeo Marini
Keyword(s):  
Ternary Mixtures ◽  
Compatibility Studies ◽  
Physico Chemical ◽  
Binary And Ternary Mixtures ◽  
Chemical Techniques ◽  
Excipient Compatibility

scholarly journals Compatibility studies of nateglinide with excipients in immediate release tablets

2011 ◽  
Vol 61 (2) ◽  
pp. 237-247 ◽  
Author(s):  
Nihar Pani ◽  
Lila Nath ◽  
Sujata Acharya
Keyword(s):  
Stress Testing ◽  
Immediate Release ◽  
Spectrophotometric Study ◽  
Magnesium Stearate ◽  
Differential Scanning Calorimetric ◽  
Compatibility Studies ◽  
Accelerated Stability ◽  
Infra Red ◽  
Isothermal Stress Testing ◽  
Excipient Compatibility

Compatibility studies of nateglinide with excipients in immediate release tabletsExperiments were done to assess the compatibility of nateglinide with selected excipients in the development of immediate release tablets of nateglinide by thermal and isothermal stress testing (IST) techniques. To evaluate the drug-excipient compatibility, different techniques such as differential scanning calorimetric (DSC) study, infra-red (IR) spectrophotometric study and isothermal stress testing were adopted. The results of DSC study showed that magnesium stearate exhibited some interaction with nateglinide. However, the results of IR, and IST studies showed that all the excipients used in the formula were compatible with nateglinide. Optimized formulations developed using the compatible excipients were found to be stable over 3 months of accelerated stability studies (40 ± 2°C and 75 ± 5% RH). Overall, compatibility of excipients with nateglinide was successfully evaluated using a combination of thermal and IST methods and the formulations developed using the compatible excipients were found to be stable.

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