Synthesis of Alginate/Nanocellulose bionanocomposite for in vitro delivery of Ampicillin

<p>In this study Ampicillin drug loaded with alginate and nanocellulose film was prepared by solution casting method. Nanocellulose and ampicillin incorporated into alginate to improve both mechanical and swelling property. The formulated ampicillin loaded Alg/NC film gave acceptable physicochemical properties compared with Alg-amp film and was able to deliver the drug in a prolonged release pattern. <em>In vitro</em> drug release showed that alginate, could provide an immediate release of ampicillin with further enhanced nanocellulose, and followed by a sustained release over 500 min of the remaining drug. The present study exhibited a simple and useful approach to systematically design for providing drug release profiles.</p>

Preparation of cyclodextrin nanoparticles and evaluation of its effect on the capacitation of bovine spermatozoa used in the in vitro fertilization

<p>This study was conducted to produce nanosized cyclodextrin (NCD) and assess its effect on bovine spermatozoa during In vitro fertilization (IVF) to optimize the capacitation media for successful IVF. Therefore, Four cyclodextrin formulations were prepared and characterized. Data analysis revealed the best formula (F2) showed a smallest particle size (15 nm), zeta potential (-37 mv), and higher yield percentages (95%) was selected for spem capacitation. Motile spermatozoa were separated from frozen-thawed semen by a swim-up procedure and capacitated in IVF-TALP medium with different formulae of NCD or CD or without treatments (control) and incubated for 3hours(hr) at 38°C and evaluated every one (hr) interval. Data analysis revealed that the formulation of cyclodextrin nanoparticles (F2<strong>)</strong> after (2hr) incubation in the media gave best effect on sperm capacitation and acrosme reaction (AR) and effect of sperm treated with NCD on fertilization rate was evaluated. The results showed that the proportion of Oocytes fertilized was increased significantly in F2 (60%) than in the control (35%), and cyclodextrin group (50%) groups (<em>p</em>&lt;0.05). It could be inferred from this investigation that cyclodextrin nanoparticles can be used for biomedical interventions in bovine spermatozoa. NCD improve sperm motility, viability, and (AR), also fertilization rate of sperm treated with NCD increase. So NCD gave positive effect on sperm functions during IVF. </p>

In vitro evaluation of Transdermal Patch of Palonosetron for Antiemetic Therapy

<p>Skin is one of the routes for systemic delivery of drugs through various drug delivery system. A transdermal Drug Delivery System (TDDS) is one of the most reliable and useful system to deliver drug systemically through skin. Generally medicated patch is placed on skin for delivery of medication through it into the blood stream. The aim of present study was to formulate and evaluate Palonosetron transdermal patch in vitro that could be used for antiemetic therapy. The incorporation ofPalonosetron a serotonin 5-HT₃ antagonist drug was envisaged. The TDDS was prepared by solvent evaporation technique and was evaluated for organoleptic characteristics and other physicochemical properties Thickness, Weight variation, Drug content uniformity, Tensile strength, % Elongation, Folding endurance &amp; Moisture content. The in vitro permeation study of the patch was carried out through KesaryChein diffusion cell as barrier membrane. Phosphate buffer pH 7.4 was used as dissolution medium and the temperature was maintained at 37 ± 1⁰C. The in vitro permeation study of the prepared patch indicated a time dependent increase in drug release throughout the study. The percentage of cumulative drug release was found to be 76.25% in 24 hours.The study shows a new approach to work in with Palonosetron.<strong></strong></p>

Quality control and standardization of FACA® syrup

<p>Sickle cell disease is a major public health problem. It is the first genetic disease in the world. FACA syrup offers an alternative treatment. It is a dry powder preparation of two components, the roots barks of <em>Zanthoxylum zanthoxyloides</em> Lam. (Rutaceae) Zepernick, Timler and <em>Calotropis procera</em>. Ait. R.B.r. (Asclepiadaceae). The product was developed at Institute for Research in Health Sciences (IRSS) from a traditional recipe used in Burkina Faso for treatment of sickle cell crises. This study aimed to establish physical-chemical, pharmaco technical and microbiological control parameters essential for the standardization of the phytomedicine. This valuation concerned specifications of moisture content, pH, the fingerprint by thin layer chromatography, pesticide residues, heavy metal content, microbial quality, and total ash. These charcteristics were determined by the methods prescribed by the World Health Organization (1998) and the European Pharmacopoeia 6th edition. The results have shown that dry syrups and reconstituted syrups were sweet, slightly spicy with a bitter after taste, a white room color and a faint odor. The density at the preparation was 0.985 and the pH was 5.93. After 2 months of storage in the laboratory, the organoleptic parameters of the reconstituted syrups have not changed. They were mold free, the density remained around 1 and the pH between 5 and 4. These parameters have shown that the quality of plants powders and these medicine comply with the recommendations of the European pharmacopoeia. Faca syrup may contribute to the better management of sickle cell disease in children.</p>

Preparation of progesterone nanoparticles and evaluation of its effect on the capacitation of Bovine spermatozoa used in the in Vitro Fertilization

<p class="Default">Progesterone (P) has been reported to affect several sperm functions especially capacitation and acrosome reaction<strong>. </strong>The main problem of (P) is its low aqueous solubility. So formulation of progesterone nanoparticles (PN) will enhance its solubility. This study was conducted to produce nanosized progesterone (NP) and assess its biocompatibility. Therefore, nine progesterone formulations were prepared and characterized. Data analysis revealed only one formula of P<span lang="EN-GB"> showed nanosized particle (1-100 nm) with an average particle size (</span><span>95±</span><span lang="EN-GB">5 nm), and spherical shape as seen by Transmission Electron Microscope(TEM).</span> Motile spermatozoa were separated from frozen-thawed semen by a swim-up procedure and capacitated in IVF-TALP medium with NP or P or without treatments (control) and incubated for 3h at 38°C and evaluated every 1 hour (h) interval. Ovarian oocytes were matured and fertilized <em>in vitro </em>with frozen-thawed bull sperm capacitated in vitro<strong> </strong>with NP or P or control (without NP, P) and incubated at 39C in 5% CO2 incubator for 24h and then examined for evidence of fertilization. In conclusion, this study demonstrates that nanosized progesterone is highly efficient for sperm capacitation. In addition to the use of nanosized progesterone in sperm capacitation produces more fertilized oocytes than the progesterone after<em> In Vitro </em>Fertilization (IVF).</p>

Investigations on noval method for the formulation of solid dispersions part- I Formulation, characterization and selection

<p>The solid dispersions of indomethacin with hydrophilic polymers were prepared by lyophilization. The polymers used in the investigation were HPMC, PVP K30, CBR and PLF 127. The solubility and dissolution of indomethacin from prepared lyophilized solid dispersions were investigated in 0.1 N HCl, purified water and USP-NF dissolution media. Out of fifteen lyophilized formulations from F1 to F15, five formulations F2, F5, F8, F12 and F14 showed highest solubility in purified water. Formulation F2, F8 failed to comply with the USP-NF dissolution test for indomethacin capsules. Formulation F14 showed maximum dissolution in the respective dissolution media within 60 min. Sustained drug release was observed for 6 h with formulations F2 and F8 in USP-NF media. The formulations F2, F5, F8, F12 and F14 were characterized by modulated DSC and FT-IR spectroscopy. Some Formulations on stability testing were found physico-chemically stable at accelerated temperature conditions.</p>

Sustained release formulation of metformin-solid dispersion based on gelucire 50/13- PEG4000: an in vitro study

<p>Metformin is a hydrophilic hypoglycemic agent with permeability and short half-life problems which leads to its low bioavailability. Solid dispersion is one of the unique approaches, to improve bioavailability profiles of drugs. The aim of this study was to prepare and evaluate solid dispersions (SDs) of metformin with polyethylene glycol 4000 (PEG 4000) and Gelucire®50/13 in order to increase its permeability and bioavailability. Solid dispersions of Metformin containing various ratios of PEG 4000: Gelucire®50/13 (1:1, 1:2, 2:1, 1:4, 4:1 as Batch A, Batch B, Batch C, Batch D and Batch E) were prepared using solvent evaporation and fusion techniques. The physical mixtures which served as controls were also prepared. The SDs were evaluated using encapsulation efficiency, percentage yield. The formulations were also characterized with FTIR and DSC. The in vitro drug release studies were also evaluated. The results obtained showed that solid dispersion formulations at pH, 1.2 and 7.4 demonstrated higher release rates than the pure drug. The SDs showed high drug release rates and encapsulation efficiency (% EE) although Batch C containing PEG 4000 and Gelucire 50/13 in the ratio of 2:1 appeared as the batch with most % EE, drug release with broad melting peak. The release rate of metformin increased with increasing amount of PEG 4000. Batch C, SDs containing PEG 4000 and Gelucire 50/13 in the ratio of 2:1 were found to be the most optimized batch with enhanced encapsulation efficiency, most drug release and therefore, improved permeability and bioavailability of metformin.</p>

Formulations and evaluation of Cyclodextrin complexed Ceadroxil loaded nanosponges

<p>Cefadroxil (CFD) is a broad spectrum antibiotic that acts against an extensive variety of bacteria, including Gram-positive and Gram-negative bacteria. The major drawback of orally administered drug like cefadroxil is its shorter half life of 1.2 hrs. The goal of the study is to prolong the drug release, producing a desired blood serum level, reduction in drug toxicity and improving the patient compliance by prolonging the dosing intervals. Cyclodextrin-based nanosponges (NS) are a novel class of cross-linked derivatives of cyclodextrins. They have been used to increase the solubility of poorly soluble actives, to protect the labile groups and control the release. This study aimed at formulating complexes of CFDwith three types of β-cyclodextrin NS obtained with different cross-linking ratio (viz. 1:2, 1:4 and 1:8 on molar basis with the cross-linker) to protect the lactone ring from hydrolysis and to prolong the release kinetics of CFD. Crystalline (F_1:2, F_1:4 and F_1:8) and paracrystalline NS formulations were prepared. XRPD, DSC and FTIR studies confirmed the interactions of CFDwith NS. XRPD showed that the crystallinity of CFD decreased after loading. CFD was loaded as much as 21%, 37% and 13% w/w in F_1:2, F_1:4 and F_1:8, respectively while the paracrystalline NS formulations gave a loading of about 10% w/w or lower. The particle sizes of the loaded NS formulations were between 450 and 600 nm with low polydispersity indices. The zeta potentials were sufficiently high (-20 to -25 mV) to obtain a stable colloidal nanosuspension. The in vitro studies indicated a slow and prolonged CFD release over a period of 24 h. The NS formulations protected the lactone ring of CFD after their incubation in physiological conditions at 37°C for 24 h with a 80% w/w of intact lactone ring when compared to only around 20% w/w of plain CFD.</p>

Synthesis and in vitro drug release studies on substituted polyphosphazene conjugates of lumefantrine.

<p class="Default"><span>The present study pertains to the delivery of antimalarial drug (Lumifantrine). In this, polyphosphazene has been used in the synthesis of polyphosphazene-linked conjugates of Lumifantrine. These polymer-linked Conjugates have been synthesized and characterized by modern analytical techniques. The <em>in-vitro</em> drug release of Lumifantrine drug conjugates: <em>p</em>-Amino benzoic acid ester substituted polyphosphazene drug conjugate <strong>(15)</strong> and Glycine methyl ester substituted polyphosphazene drug conjugate <strong>(21) </strong>have been found to be 6.00 % and 5.96% (pH 1.2), 88.52% and 79.86% (pH 7.4), respectively. These drug conjugate may prove an effective delivery system for the treatment of malaria.</span></p>

Regulatory aspects of medical devices in India

<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p>