FORMULATION DEVELOPMENT AND EVALUATION OF ELEMENTARY OSMOTIC TABLET OF LISINOPRIL DIHYDRATE

Objective: Lisinopril Dihydrate is one of the antihypertensive drug used to control the high blood pressure. Osmotically Controlled release tablet of Lisinopril Dihydrate was performed for reducing dosing frequency and patient compliance.Methods: Elementary osmotic tablets of Lisinopril Dihydrate were developed using Sodium chloride as a key ingredient which gives osmogent property which provides driving force inside the core tablet and which leads to release of the drug. Microcrystalline cellulose used as a release retardant material in the present work. Different formulations were prepared by varying the concentrations using 32 factorial designs. It was applied to see the effect of variables Sodium chloride (X1) and MCC (X2) on the response percentage drug release as a dependent variable. These formulations were evaluated for, Hardness, Flow property, Thickness, Friability, Drug content and In vitro drug release. Tablets were coated with a semipermeable membrane using 5% w/v cellulose acetate(CA) in acetone and PEG 400(1%) used as Plasticizer. Coated Elementary osmotic tablets were drilled for delivery orifice using a standard micro drill of diameter size 0.8 mm.Results: Drug release rate was increased as the increase in the concentration of sodium chloride and release rate decreased on increasing the concentration of MCC. Drug release rate was directly proportional to delivery orifice size. SEM Study carried out for detection of diameter size of the delivery orifice. The FTIR studies demonstrate that there was no interaction between polymer and drug.Conclusion: The optimized formulation was stable for 3 mo of accelerated stability stud

SOLUBILITY AND DISSOLUTION ENHANCEMENT OF PIOGLITAZONE USING SOLID DISPERSION TECHNIQUE

Objective: To design the study to improve the solubility and hence enhance the dissolution of hydrophobic drug Pioglitazone in order to increase its bioavailability.Methods: Solid dispersion of Pioglitazone using carriers Poloxomer 188 and HPβCD was formulated in different ratios by microwave induced fusion method. In particular, the Microwave technology has been considered in order to prepare an enhanced release dosage form for poorly water soluble drug Pioglitazone. Statistical Analysis: Their physicochemical characteristics and solubility were compared to the corresponding dispersions and marketed drug. Drug and polymer were further characterized by FTIR.Results: The results of FTIR revealed that no chemical interaction between the drug and the polymer exist.Conclusion: All the formulations showed a marked increase in drug release with the increase in the concentration of Poloxomer 188 and HPβCD.Â

International Journal of Biopharmaceutics BIOSIMILARS: GLOBAL SCENARIO AND CHALLENGES

ABSTRACT Biologics are a major growth driver for global pharmaceutical market. Biosimilars are those biologics which are developed after patent expiration of innovator biopharmaceuticals. They are known as similar biologics, follow-on biologics, follow-on protein products, subsequent-entry biologics, bio-comparables, second-entry or off-patent biotechnology or multisource products in different countries. They require separate marketing approval since they are not generic versions of biologics. They are rather new molecules owing to a number of heterogeneities as compared to the reference innovator biologics. Hence, they require full documentation on quality, safety and efficacy. Several challenges in the form of structural variability, immunogenicity, regulatory, etc. impede the way of growth of biosimilars. Structural variability results due to the complexity of structure of biologics. Immunogenicity is inherent to these products since they are proteins. The lack of a robust regulatory framework poses a risk to patient safety. This article aims to highlight the biosimilars scenario on a global basis and it throws light on the regulatory guidelines of different countries. It also discusses the major challenges involved therewith. It also considers some trends that promise the bright future of biosimilars

Extraction of rutin from tagetes erecta (Marigold) and preparation of peroral nano-suspension for effective antitussive/expectorant therapy

The present study narrates the extraction of rutin from Tagetes erecta (Marigold) via maceration followed by ultrasonication. The extracted rutin was further fabricated into nanoparticles by high-pressure homogenization (HPH) and assessed by HPLC, DSC, XRD, TEM, and FTIR spectroscopy. The optimized batch of nanoparticles obtained using 32 central composite design (CCD) which exhibited particle size 209±14 nm, PDI 0.234±0.06, and 92±1.3% entrapment efficiency. The lyophilized rutin nanoparticles were further converted into nano-suspension. Interestingly, the rutin nano-suspension exhibited a similar antitussive effect in vivo as that by standard treatment pentoxyverine and reduced the coughing times within 2 min. Also, the phlegm showed high UV absorbance, implying its better expectorant activity than the standard and control. The rutin nano-suspension was highly stable and shelf life was found to be ∼29.1 months. The present study, for the first time, paves a way for the use of rutin nano-suspension to overcome chest congestion, shortening of breath, and in the management of cough