DRUG AND EXCIPIENT PROFILE DRUG NAME: LOVASTATIN (LST) PHARMACOLOGICAL CATEGORIES: Lipid Lowering Agent Anti-Neoplastic Agent HMG-CoA Reductase Inhibitors. DESCRIPTION: It was discovered by Alfred Albert and his team in 1978 at Merck. It was isolated from fungus Aspergillus terreus and is also known as Mevinolin. This was the second compound identified of this class and is two times potent than the first discovered statin Mevastatin. Lovastatin (LST) is structurally similar to hydroxyl methylglutarate
4.2 PREFORMULATION STUDIES PREFORMULATION STUDIES Preformulation testing is an investigation of physical and chemical properties of a drug substance alone and when combined with excipients. It is the first step in the rational development of dosage forms. Preformulation commences when a newly synthesized drug shows sufficient pharmacologic promise in animal models to warrant evaluation in man. These studies should focus on those physicochemical properties of the new compound that could affect drug
granules during compression. Roll compacted blend showed problem during milling process and also showed flow variation due to rat holling in the hopper during compression. 8.4 Evaluation of powder blend Blends were prepared by mixing all the excipients. The blends were evaluated for different parameters and it was observed that moisture content was NMT 3% for each blend, Carr's Index (%) was in the range of 13.44±0.02 to 16.20±0.03, Hausner's
Also, the present work aimed to improve patient compliance suffering from migraine attack. Liquisolid systems of Zolmitriptan were prepared utilizing a mathematical model for the calculation of the required amounts of excipients necessary for the production of an acceptable compressible and flowable powder blend. Preliminary screening was applied to optimize Zolmitriptan liquisolid systems that have acceptable flow properties and enhanced drug dissolution rate by utilizing
Dosage forms usually are made up of the active compound and other ingredients known as excipients. Excipients can have many functions, they can act as fillers, lubricants, binders, preservatives and antioxidants. A change in the nature of the excipients can significantly affect the stability of the active ingredient as well as its release from the dosage form. Changes in the preparation (the way the compound is made)
Liquisolid compacts: Means the formulation of immediate or sustained release dosage forms( tablets or capsules), formulated with addition of suitable excipient required for tabletting; like lubricants, binders or disintegrants.. 2. Liquisolid microsystem: Relies on a recent model which utilize same method used for formulation of liquisolid compacts combines with the addition of additives (e.g. poly vinyl
one of them. The aim of this work was to design a mucoadhesive disc and formulation studies. Material&Methods: Discs containing 10% stem bark extract of ziziphus jujuba were formulated by Zinc Oxide, Glycerin, Carbopol 34, PVP K30 and Gelatin as excipients. These materials were mixed and changed to granules and then discs through direct compression. Properties such as in vitro and in vivo mucoadhesion, drug release, water uptake, disintegration were carried out. Results: Properties of the discs showed
ingredient in the same dosage form and to meet the same or compendial or other applicable standards (ie, strength, quality, purity, and identity), but they may differ in characteristics such as shape, scoring configuration, release mechanisms, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within
“First you take a drink, then the drink takes a drink, then the drink takes you.” A quote by Francis Scott. Alcohol is one of the most enjoyed drinks in Australia. But what is so good about it? Well most kid see their parents drinking at a young age and think that is what parents do for fun and most kids follow what their parents do and people’s brains don’t full grow until the age of 25. If that is the cast why is the legal drinking age 18 and not 21? Nearly 1 in 14 Australians drink every day
or in wet granulations. Granulations containing mannitol have the advantage of being dried easily. Specific tablet applications include antacid preparations, glyceryl trinitrate tablets, and vitamin preparations. Mannitol is commonly used as an excipient in the manufacture of chewable tablet formulations because of its negative heat of solution, sweetness, and ‘mouth feel’. 4.2.4 Hypromellose / Hydroxypropyl methylcellulose52,67 1) Nonproprietary Names BP: Hypromellose JP:
Solubility Enhancement by Chemical Modification Method Abstract Solubility, the phenomenon of dissolution of solute in solvent to give a homogenous system. It is an important parameters to achieve optimum concentration of drug in systemic circulation for desired pharmacological response. Oral route is the most desirable and preferred method of administering therapeutic agents for their systemic effects, but poor solubility of drug major problem encountered with formulation development
Figure 15: FTIR spectra of pantoprazole sodium+kollicoat MAE 30DP Drug-excipient compatability studies: FTIR In the FTIR spectra of pure drug and different polymers it is observed that the peaks of major functional groups which are present in spectrum of pure drug are observed in combination of drug and polymers. There was no
3600-3500 3421.41 C=o stretch 1750 1740.39 C-O stretch 1100 1076.62 C=C stretch 1650-1550 1569.68 Comments for compatibility: All IR spectra of pure compound and its composition with excipients in formulation are same. This indicates that there was no structural change caused by excipients. 7.2 Optimization of Process Variable The preparation procure was accordingly optimized and validated on the basis of following process variable Table 13: Effect of temperature Temperature
RESULTS & DISCUSSIONS PREFORMULATION: S.NO API CHARACTERISATION RESULTS 1 Physical Appearance Mycophenolate mofetil white to off-white crystalline powder 2 Melting point 93-94ºC 3 solubility Freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. Table 3: Characterization of API Calibration Curve of Mycophenolate mofetil: Calibration Curve of Mycophenolate mofetil in pH 7.4 PBS Solvent pH 7.4 phosphate buffer Saline (PBS) Wave length 253 nm Unit for concentration mcg/mL
1. INTRODUCTION 1.1. CYCLODEXTRIN1, 2, 3:- For drugs to be pharmacologically active, they essential have assured degree of water solubility, and also maximum of them should be lipophilic in instruction to be permeable to the biological membranes through passive diffusion. The water solubility of drug is characterized by its potency and its type of formulation. The hydrophilic property will prevent the dissolved drug molecule to separate from the hydrous exterior into a lipophilic bio membrane and
Generic is an analog of the famous drug. Generic Viagra contains the same active substance. The differences are may be in the excipients. Generic Viagra cannot be fake since their manufacture and sale are legal. Certificates that confirm the impeccable quality and effectiveness accompany each drug. Viagra does not affect libido or hormones; they do not inhibit the person's emotional
- 124ºC) as reported in literature, thus indicating purity of Metoprolol Tartrate. FTIR analysis showed that all the characteristic peaks of Metoprolol Tartrate and mixture of Metoprolol Tartrate with excipients were present in the range of reported frequencies; which shows that drug and excipients were compatible with each other. DSC thermogram of Metoprolol Tartrate alone showed endothermic peak at 120.73°C, corresponding to the melting point of the drug. The thermal curve of the Metoprolol Tartrate
Ameya J. Limaye PMCY 6510 Take Home Final Exam A. Reference drug product: Janumet XR (sitagliptin phosphate and metformin HCl extended release tablets) Selected dosage strength: 50mg sitagliptin, 500mg metformin (once daily for naïve patients currently not treated with metformin) B. Active pharmaceutical ingredients: 1. Sitagliptin: Sitagliptin is an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Inhibition of DPP-4 prevents breakdown of GLP-1and GIP and allows for an extended
need to make or break covalent bonds, theoretical capability of all types of API molecules (weakly ionizable/non-ionizable) to form co-crystals, the existence of diverse potential counter-molecules (food additives, preservatives, pharmaceutical excipients, and different APIs), the sole solid type that 's designable via crystal engineering patentable increasing information science portfolios and can be produced using solid-state synthesis green technologies high yield, no solvent or by-products. Solvates
The data of this experiment demonstrate that hard gelatin capsules are a modern dosage form for medicinal use, stemming from the increased emphasis on pharmacokinetics found in drug development today. This has considerably expanded the range of possible formulations utilizing hard gelatin capsules as simple dosage form for oral drug delivery. Nowadays, modern capsule-filling machines can produce up to 200,000 capsules an hour and are also capable of filling in a number of different substances in