The aim of the present investigation was to develop sustained release ethylcellulose-coated egg albumin microspheres of diltiazem hydrochloride (DH) to improve patient compliance. The microspheres were prepared by the w/o emulsion thermal cross-linking method using different proportion of the polymer to drug ratio (1.0:1.0, 1.0:1.5 and 1.0:2.0). A 32 full factorial design was employed to optimize two independent variables, polymer to drug ratio (X1) and surfactant concentration (X2) on dependent variables, namely % drug loading, % drug release in 60 min (Y60) and the time required for 80 % drug release (t80) were selected as dependable variable. Optimized formulation was compared to its sustained release tablet available in market. The polymer to drug ratio was optimized to 1:1 at which a high drug entrapment efficiency 79.20% ± 0.7% and the geometric mean diameter 47.30 ± 1.5 mm were found. All batches showed a biphasic release pattern; initial burst release effect (55% DH in 1 h) and then were released completely within 6 h. In situ coating of optimized egg albumin DH microspheres using 7.5% ethylcellulose significantly reduced the burst effect and provided a slow release of DH for 8-10 h. Finally, it was concluded that ethylcellulose-coated egg albumin DH microspheres is suitable for oral SR devices in the treatment of angina pectoris, cardiac arrhythmias, and hypertension due to their size and release profile.
The aim of the present work was to study the dissolution behaviour of a poorly water-soluble Olmesartan Medoxomil (class II drug), by forming polymeric micelles (PMs) of SoluPlus and Pluronic F127. Polymeric Micelles of SoluPlus and Pluronic F127 were prepared by the co-solvent evaporation method. Drug and excipient compatibility study were carried out by Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry. The formulations were evaluated for particle size, Zeta Potential, Solubility studies, drug loading and encapsulation efficiency. Scanning Electron Microscopy (SEM) analysis was performed to study the surface morphology of the PMs. The SEM images showed spherical surface of the micelles. The drug loading efficiency was more for SoluPlus micelles compared to Pluronic F127 micelles. The Polymeric micelles showed negative zeta potential value indicating that they are stable and resist aggregation. The particle size was around 100nm and polydispersity index was less than 1 indicating uniform size distribution. The drug release from the SoluPlus micelles was higher than the Pluronic micelles. These results suggest that the polymeric micelles can be used to increase the solubility of poorly water-soluble drugs.
The best recognized and also the most widespread example of tissue necrosis is bedsore. A bedsore is localized damage to the skin and other underlying tissue, usually over a bony prominence, as a result of prolonged, unrelieved pressure. The cause of bedsore is shearing forces; friction, moisture, and constant pressure contribute to the development of bedsore. Hospital research shows that bedsores develop from 3% to 4.5% of patients during prolonged hospitalization and Sores develop from 25% to 85% of patients with spinal cord injury. The doctor and nurses will regularly examine the patient who is at risk of developing bedsore and inspect each pressure sites at least twice a day. Doctors and nurses are important warriors who manage bedsore treatment effectively. This review describes the new strategies have been used to prevent and management of bedsore such as inexpensive foam devices, anti-pressure devices, air-filled equipment, a sheet of hydrogels, wound vacuum-assisted closer, skin bioprinting, and Lab VIEW virtual instrument.
Annual Product Quality Review (APQR) is an estimation prepared according to the Current Good Manufacturing Practice (CGMP) requirements of different regulatory authorities. A Good Manufacturing Practice (GMP) ensures that the products are constantly produced and controlled according to quality standards. APQR is not only required for GMP but also required for the quality improvement of the pharmaceutical product. APQR is an evaluation carried out annually to measure the standard of quality of each drug with an intention to verify the constancy of current process and to check the correctness of current speci ications and to highlight any trend in order to determine the need to change any drug product speci ications or the manufacturing processes or control procedures. It is a written report that is required for every drug, based on the data that was collected in the previous year. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the inished product. The APQR is globally accepted by the industry and the contents should specify a list of manufactured batches, release data and reviews of deviations, complaints, recall and returned goods. This article gives brief overview of regulatory aspects and regulatory requirements for Annual Product Quality Review of pharmaceutical product. It mainly focusses on the documentation required for the preparation of Annual Product Quality Review. Thus the article is based on the regulatory requirements or standards to manufacture and maintain the quality of any pharmaceutical product.
: Diabetes mellitus is found to be among the most suffered and lethal diseases for mankind. Diabetes mellitus type-1 is caused by the demolition of pancreatic islets responsible for the secretion of insulin. Insulin is the peptide hormone (anabolic] that regulates the metabolism of carbohydrates, fats, and proteins. Upon the breakdown of the natural process of metabolism, the condition leads to hyperglycemia (increased blood glucose levels]. Hyperglycemia demands outsourcing of insulin. The subcutaneous route was found to be the most stable route of insulin administration but faces patient compliance problems. Oral Insulin delivery systems are the patient-centered and innovative novel drug delivery system, eliminating the pain caused by the subcutaneous route of administration. Insulin comes in contact across various barriers in the gastrointestinal tract, which has been discussed in detail in this review. The review describes about the different bioengineered formulations, including microcarriers, nanocarriers, Self-Microemulsifying drug delivery systems (SMEDDs), Self-Nanoemulsifying drug delivery systems (SNEDDs), polymeric micelles, cochleates, etc. Surface modification of the carriers is also possible by developing ligand anchored bioconjugates. A study on evaluation has shown that the carrier systems facilitate drug encapsulation without tampering the properties of insulin. Carrier-mediated transport by the use of natural, semi-synthetic, and synthetic polymers have shown efficient results in drug delivery by protecting insulin from harmful environment. This makes the formulation readily acceptable for a variety of populations. The present review focuses on the properties, barriers present in the GI tract, overcome the barriers, strategies to formulate oral insulin formulation by enhancing the stability and bioavailability of insulin.
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