ABSTRACT

In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced auditors decades to develop. It follows the auditing guidance of ISO-19011 and is a virtual audit of a manufacturing facility that makes a range of dosage forms. This allows you to plan and prepare audits of the supplier and your own supplier audit system. Throughout the course, there is personal practice with exercises and teamwork’s in planning, preparation and performance that address WHO. The extensive of course notes and excellent lectures given by knowledgeable and professional tutors in pharmaceutical industry, The WHO was very easy to approach with any problems in during the course. The purpose of regulatory authorities to assess application for authorization to market products for human use and either grant authorizations to market each product or reject such applications and inspect the manufacturers and wholesalers of medicines for human use and either grant manufacturing and wholesale licenses or refuse such licenses. The international regulatory authorities under consideration are in this article WHO, USFDA, MHRA, and Australian TGA. The standard institutions give the economical background for development and transferring technologies, ISI, ISO, BISS and ASTM. 

Keywords: Regulatory authority, WHO, Self-auditing, Standard institution

ABSTRACT

The present study was aimed at the formulation of transdermal patches of flupirtine maleate containing different permeation enhancers. It acts indirectly as N-methyl-D-aspartate (NMDA) receptor antagonist and activates the K⁺ channels; thereby acts as a skeletal muscle relaxant. Flupirtine maleate transdermal patches are intended to provide localized effect. The patches were prepared by solvent evaporation technique, using polyvinyl alcohol (PVA) as the polymer whereas dimethyl sulfoxide (DMSO) and polyethylene glycol (PEG-400) as the permeation enhancers. Methanol was used as a solvent to dissolve the drug and glycerol was used as the plasticizer. These patches were evaluated for in vitro permeation, tensile strength, percent moisture absorption, drug content uniformity, film thickness, weight variation and folding endurance. All the patches showed extended release properties. Formulation FDD8 containing 8% polymer and 2% DMSO was found to be the optimized formulation on the basis of evaluation parameters. In vitro permeation release was found to be 95.71 ± 0.01% at the end of 12 h. As the concentration of DMSO increased, the release profile of drug was enhanced. This indicated that DMSO improved the release profile of flupirtine maleate when compared to PEG-400. The release kinetics of the transdermal patches followed Higuchi matrix model. The stability studies showed that all the optimized patches were stable during their study period. From the present study, it can be concluded that addition of DMSO yields good result to enhance the permeation of the drug.

Keywords: flupirtine maleate, transdermal patch, permeation enhancers, dimethyl sulfoxide DMSO, polyethylene glycol PEG-400, polyvinyl alcohol PVA.

ABSTRACT

Methimazole is active pharmaceutical ingredient effectively utilized in hyperthyroidism. Methimazole inhibits peroxidase as well as iodine interactions with thyroglobulin to produce triiodothyronine with thyroxine. Methimazole shows very low protein binding (1-10%) bounds to plasma proteins and easily metabolized by liver. In this investigation, efforts given to develop a sustained release matrix tablet of Methimazole. Sustained release drug delivery systems are for a maximum of 24 hours clinical effectiveness. Such systems are primarily for the drugs of short elimination half-life. However, drugs with long half-life also qualify if a reduction in steady state fluctuation is desired. Matrix tablets of methimazole were prepared by utilizing direct compression method. HPMC along with Sodium carboxy methyl cellulose used to retard drug release from the dosage form. Matrix tablets of methimazole were evaluated for different quality control test to improve quality of the product. In vitro release study of methimazole matrix tablets shows that polymer percentage used in the formula is enough to extend the release of the drug for at least 12 hr. In dissolution study of matrix of methimazole formulation F2 shows maximum drug release 97.93 % at the end of 6 hours while F1 shows least 83.64 %.

Keywords: Matrix tablet, Methimazole, Sustained Release

ABSTRACT

To improve the solubility enhancement of solid dispersion of Lopinavir by spray-drying by adding the Soluplus as polymer that is compatible with Lopinavir, was evaluated and the process used for preparation of Spray dried solid dispersion was validated and the 1:3 ratio used for preparation of solid dispersion. Dissolution tests were carried out on several spray dried solid dispersion of Lopinavir and physical mixture. The solid dispersion characterized by DSC, XRD, % Entrapment Efficiency, solubility study, drug content determination, practical yield, dissolution studies.

Keyword: Lopinavir, Soluplus, Spray Drying Technique, Dissolution studies.

ABSTRACT

Gout is a disease caused by the deposition of monosodium urate (MSU) crystals in tissue such as cartilage, synovial membranes, bones and skin which causes inflammation in the synovial tissue. Indomethacin is first line of drug used as NSAID for the treatment of Gout. The aim of this study was to encapsulate Indomethacin in ethyl cellulose microspheres and compare the efficiency of the formulated Indomethacin microspheres with the Marketed formulation. Indomethacin microspheres were prepared by solvent evaporation method. FTIR  studies revealed there was no significant interaction between the drug and polymer. Preformulation studies gave satisfactory results. SEM studies showed a spherical smooth microsphere average size of 10.4±3.04. The percentage entrapment efficiency and percentage drug release after 10 hours was found to be 82.97±1.6 % and 52.04±0.58 % respectively. The therapeutic effect of the Indomethacin microspheres was evaluated by the swelling of knee joints, joint range of motion and histologic analysis of MSU induced rat model. The prepared indomethacin microspheres showed effective prolong in the retention time of the drug in the intra articular cavity to 30 d which is more than that of the marketed formulation. Intra- articular injection of Indomethacin microspheres efficiently relieved inflammatory symptoms such as swelling index, joint range motion and suppressed inflammatory cell infiltration than the marketed formulation. Thus intra-articular injection of Indomethacin loaded microspheres proved to be a promising therapeutic method in the treatment of Gout.

Keywords: Gout, indomethacin, ethyl cellulose, microspheres, inta-articular

ABSTRACT

Mouth dissolving tablet disintegrates and dissolves rapidly in the saliva, within a few seconds without the need of drinking water or chewing. A mouth dissolving tablet usually dissolves in the oral cavity within 15 seconds to 3 minutes. Almotriptan malate is an anti migraine drug with bitter taste and shows hepatic metabolism.  In the present work, Mouth dissolving tablets of almotriptan malate were prepared by direct compression method using sodium starch glycolate and croscarmellose sodium as superdisintegrant with a view to enhance patient compliance and to avoid gastric dysmotility which is common with migraine drugs and for fast action of drug. The prepared batches of tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water-absorption ratio and in-vitro dispersion time. Short-term stability studies on the promising formulation indicated that there are no significant changes in drug content and disintegration time.

Keywords: Almotriptan malate, Superdisintegrant, Sodium starch glycolate, Crosscarmellose sodium, Taste masking.

ABSTRACT

Bronchiolitis is a common lung infection in young children and infants. It causes inflammation and congestion in the small airways (bronchioles) of the lung. Bronchiolitis is almost caused by a virus. Bronchodilators are medication which makes breathing easier by relaxing the muscles in the lungs and widening airways. To assess the efficacy and risk associated with the use of bronchodilators in pediatric patients with bronchiolitis.  To assess the Efficacy of Bronchodilators, to evaluate the risk associated with bronchodilators in bronchiolitis patients and to evaluate the patient compliance in patients using bronchodilator for bronchiolitis. This study was conducted in 10 bronchiolitic pediatric patients. This study was conducted by categorizing the patients according to their Respiratory Rate, SpO2 and Heart Rate values. Patient compliance is analyzed using CRS scale and risk is assessed with Wang Scale.

Keywords: Bronchiolitis, Bronchodilators, Levosalbutamol

ABSTRACT

The objective of this research work was to carry out design and evaluation of sustained release matrix tablets of Itopride by use of natural and synthetic polymers.  Matrix tablets were prepared by wet granulation technique by using natural polymers like Carbopol 934, Tamarind poly saccharide, Locust bean gum, Ethyl cellulose, HPMC K 100 as matrix forming agent and excipients such as Lactose, Starch 1500, Magnesium stearate, MCC and talc were used. The dissolution medium consisted of 900 ml of 0.1 N HCl for first 2 hours and then 7.4 phosphate buffer for remaining 10 hours. The release of Itopride from matrix containing lactose, micro crystalline cellulose and starch 1500 as diluents. The drug release rate was found in order of lactose> micro crystalline cellulose>starch 1500. The formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The release data were fit into different kinetic models (zero-order, first-order, Higuchi’s equation and Korsmeyer-Peppas equation). Optimized formulation was tested for their compatibility with Itopride by FT-IR studies, which revealed that there is no chemical interaction occurred with polymer and other excipients. The drug release profile of the best formulation was well controlled and uniform throughout the dissolution studies.

Keywords: Matrix tablets, Itopride, Carbopol 934, HPMC K 100, Ethyl cellulose.

Dipeptidyl peptidase IV is a key regulator of insulin- stimulating hormones, glucagon-like peptide and glucose dependent insulinotrophic polypeptide. Thus it is a promising target for treatment of type 2 Diabetes mellitus. Inhibition of plasma Dipeptidyl peptidase IV enzyme lead to enhanced endogenous glucagon like peptide-1, GIP activity which ultimately results in the potentiating of insulin secretion by pancreatic cell and subsequent lowering blood glucose level, HbA [1c], glucose secretion, liver glucose production. One of the principal goals of diabetes management is to attain haemoglobin HbA [1c] treatment goals and prevent the onset or decrease the rate of occurrence of Microvascular conditions.2, 6 numerous treatment options are available for management of Type 2 Diabetes mellitus, various class of DPP IV inhibitor being explored such as Sitagliptin and Vildagliptin successfully launched. Several other novel DPP IV inhibitors are in pipeline, Unless there are clear contraindications, metformin monotherapy is prescribed, and if HbA [1c] targets are not attained after 3 months, 1 of several classes of agents could be added, such as sulfonylurea’s, Thiazolidinediones, dipeptidyl peptidase-4 inhibitors, - glucagon like peptide-1 receptor agonists, or basal insulin.2,6 Despite the broad range of therapeutic options, the attainment of HbA [1c] goals among patients with diabetes remains challenging, with just slightly more than half (52%) of diabetes patients attaining the common HbA [1c] goal of < 7.0%. The present review summarizes latest preclinical and clinical trial data of different DPP IV inhibitors with a special emphasis on their DPP8/9 fold selectivity and therapeutic advantages over GLP-1 based approach.

Keywords: Diabetes 2, Dipeptidyl Peptidase-4, glucose-dependent insulinotrophic polypeptide, glucagon-like peptide-1.