Characterization of an Active Pharmaceutical Ingredient by Its Dissolution Properties: Amoxicillin Trihydrate as a Model Drug

Chemotherapy ◽  
2004 ◽  
Vol 50 (5) ◽  
pp. 234-244 ◽  
Author(s):  
Stefan Horkovics-Kovats
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Dissolution Properties ◽  
Amoxicillin Trihydrate ◽  
Model Drug

Glibenclamide-Nicotinamide Cocrystals Synthesized by The Solvent Evaporation Method to Enhance Solubility and Dissolution Rate of Glibenclamide

2019 ◽  
Vol 9 (01) ◽  
pp. 21-26
Author(s):  
Arif Budiman ◽  
Ayu Apriliani ◽  
Tazyinul Qoriah ◽  
Sandra Megantara
Keyword(s):  
Solvent Evaporation ◽  
Physical Mixture ◽  
Dissolution Profile ◽  
Solvent Evaporation Method ◽  
X Ray Diffraction ◽  
Scanning Calorimetry ◽  
Evaporation Method ◽  
Dissolution Properties ◽  
Mixture Characterization

Purpose: To develop glibenclamide-nicotinamide cocrystals with the solvent evaporation method and evaluate their solubility and dissolution properties. Methods: Cocrystals of glibenclamide-nicotinamide (1:2) were prepared with the solvent evaporation method. The prediction of interactive cocrystals was observed using in silico method. The solubility and dissolution were performed as evaluation of cocrystals. The cocrystals also were characterized by differential scanning calorimetry (DSC), infrared spectrophotometry, and powder X-ray diffraction (PXRD). Result: The solubility and dissolution profile of glibenclamide-nicotinamide cocrystal (1:2) increased significantly compared to pure glibenclamide as well as its physical mixture. Characterization of cocrystal glibenclamide-nicotinamide (1:2) including infrared Fourier transform, DSC, and PXRD, indicated the formation of a new solid crystal phase differing from glibenclamide and nicotinamide. Conclusion: The confirmation of cocrystal glibenclamide-nicotinamide (1:2) indicated the formation of new solid crystalline phases that differ from pure glibenclamide and its physical mixture

Physicochemical Characterization of Solid Dispersions of Cefdinir with PVP K-30 and PEG 4000

2010 ◽  
Vol 3 (2) ◽  
pp. 948-956
Author(s):  
Kumar P ◽  
S Kumar ◽  
A Kumar ◽  
M Chander
Keyword(s):  
Solid Dispersions ◽  
Physicochemical Characterization ◽  
Drug Carriers ◽  
Dissolution Properties ◽  
Rate Of Dissolution ◽  
Peg 4000 ◽  
Release Studies ◽  
Crystalline Nature ◽  
Physical Mixtures

The purpose of this study was to prepare and characterize solid dispersions of the antibacterial agent Cefdinir with PEG 4000 and PVP K-30 with a view to improve its dissolution properties. Investigations of the properties of the dispersions were performed using release studies, X-ray powder diffraction (XRD) and Fourier transform infrared (FTIR). The results obtained showed that the rate of dissolution of Cefdinir was considerably improved when formulated in solid dispersions with PVP K-30 and PEG 4000 as compared with pure drug and physical mixtures. The results from XRD studies showed the transition of crystalline nature of drug to amorphous form, while FTIR studies demonstrated the absence of drug-carriers interaction.

scholarly journals Design and Characterization of Buccoadhesive Liquisolid System of an Antihypertensive Drug

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Nilesh P. Kala ◽  
Divyesh H. Shastri ◽  
Pragna K. Shelat
Keyword(s):  
Ex Vivo ◽  
Flow Parameters ◽  
Mucoadhesive Polymers ◽  
Dissolution Properties ◽  
Powder Characteristics ◽  
Bioadhesive Polymers ◽  
Tablet Formulations ◽  
Permeability Studies ◽  
Aluminium Silicate

Nifedipine is an antihypertensive BCS class II drug which has poor bioavailability when given orally. The objective of the present study was to increase the bioavailability of nifedipine, by formulation and evaluation of a buccoadhesive liquisolid system using magnesium aluminium silicate (Neusilin) as both carrier and coating material and dissolution media were selected based on the solubility studies. A mixture of carboxymethylcellulose sodium and carbomer was used as mucoadhesive polymers. Buccoadhesive tablets were prepared by direct compression. FTIR studies confirmed no interaction between drug and excipients. XRD studies indicated change/reduction in crystallinity of drug. The powder characteristics were evaluated by different flow parameters to comply with pharmacopoeial specifications. The dissolution studies for liquisolid compacts and tablet formulations were carried out and it was found that nifedipine liquisolid tablets formulated from bioadhesive polymers containing 49% liquisolid system, 17.5% carbomer, and 7.5% carboxymethylcellulose sodium showed the best results in terms of dissolution properties. Prepared formulation batches were evaluated for swelling, bioadhesion strength, ex vivo residence time, and permeability studies. The optimized batch was showing promising features of the system. Formulating nifedipine as a buccoadhesive tablet allows reduction in dose and offers better control over the plasma levels.

Preparation and Physicochemical Characterization of Acyclovir Cocrystals with Improved Dissolution Properties

2013 ◽  
Vol 102 (11) ◽  
pp. 4079-4086 ◽  
Author(s):  
Giovanna Bruni ◽  
Mariarosa Maietta ◽  
Lauretta Maggi ◽  
Piercarlo Mustarelli ◽  
Chiara Ferrara ◽  
...  
Keyword(s):  
Physicochemical Characterization ◽  
Dissolution Properties

Characterization of low-abundance species in the active pharmaceutical ingredient of CIGB-300: A clinical-grade anticancer synthetic peptide

2018 ◽  
Vol 24 (6) ◽  
pp. e3081 ◽  
Author(s):  
Hilda Garay ◽  
Luis Ariel Espinosa ◽  
Yasser Perera ◽  
Aniel Sánchez ◽  
David Diago ◽  
...  
Keyword(s):  
Synthetic Peptide ◽  
Active Pharmaceutical Ingredient ◽  
Clinical Grade

Development and Characterization of a Cocrystal as a Viable Solid Form for an Active Pharmaceutical Ingredient

2013 ◽  
Vol 17 (3) ◽  
pp. 540-548 ◽  
Author(s):  
Soojin Kim ◽  
Zhibin Li ◽  
Yin-Chao Tseng ◽  
Herbert Nar ◽  
Earl Spinelli ◽  
...  
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Solid Form

scholarly journals Spectroscopic Characterization of Omeprazole and Its Salts

2017 ◽  
Vol 2017 ◽  
pp. 1-11
Author(s):  
Tomislav Vrbanec ◽  
Primož Šket ◽  
Franci Merzel ◽  
Matej Smrkolj ◽  
Jože Grdadolnik
Keyword(s):  
Vibrational Spectroscopy ◽  
Alkali Metals ◽  
Alkaline Earth ◽  
Active Pharmaceutical Ingredient ◽  
Spectroscopic Characterization ◽  
Infrared And Raman Spectroscopy ◽  
Acid Environment ◽  
Ph Range ◽  
Spectroscopic Tool

During drug development, it is important to have a suitable crystalline form of the active pharmaceutical ingredient (API). Mostly, the basic options originate in the form of free base, acid, or salt. Substances that are stable only within a certain pH range are a challenge for the formulation. For the prazoles, which are known to be sensitive to degradation in an acid environment, the formulation is stabilized with alkaline additives or with the application of API formulated as basic salts. Therefore, preparation and characterization of basic salts are needed to monitor any possible salinization of free molecules. We synthesized salts of omeprazole from the group of alkali metals (Li, Na, and K) and alkaline earth metals (Mg, Ca). The purpose of the presented work is to demonstrate the applicability of vibrational spectroscopy to discriminate between the OMP and OMP-salt molecules. For this reason, the physicochemical properties of 5 salts were probed using infrared and Raman spectroscopy, NMR, TG, DSC, and theoretical calculation of vibrational frequencies. We found out that vibrational spectroscopy serves as an applicable spectroscopic tool which enables an accurate, quick, and nondestructive way to determine the characteristic of OMP and its salts.

scholarly journals APPLICATION OF LIQUID CHROMATOGRAPHY COUPLED WITH MASS SPECTROMETRY IN THE IMPURITY PROFILING OF DRUG SUBSTANCES AND PRODUCTS

2018 ◽  
Vol 11 (5) ◽  
pp. 30
Author(s):  
Akshatha H S ◽  
Gurupadayya Bm
Keyword(s):  
Mass Spectrometry ◽  
Liquid Chromatography ◽  
High Sensitivity ◽  
Pharmaceutical Formulations ◽  
Active Pharmaceutical Ingredient ◽  
Hyphenated Techniques ◽  
Drug Substances ◽  
Impurity Profiling ◽  
Short Period

As the drug safety and efficacy is hampered in the presence of an impurity, the international regulatory agencies laid down stringent limits for the control of impurities in the active pharmaceutical ingredient and pharmaceutical formulations. The conventional approaches lack the characterization of impurities in trace levels, due to sensitivity issues, hyphenated techniques are preferred. Among the modern hyphenated techniques, liquid chromatography-mass spectrometry (LC-MS) has high sensitivity and can analyze large number of organic compounds in a short period of time. In the present study, the impurity profiling of various drug substances and products using LC-MS about past 6 years were retrospect for its importance, instrumentations, and applications.

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