Informatics Publishing Limited

Poonam R. Songire ¹, Smita S. Aher ², R. B. Saudagar ²

Affiliations
1 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik- 422213, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik- 422213, Maharashtra, IN

Abstract

Oral drug delivery is the leading and the oldest segment of the total drug delivery system in the market. It is the greatest growing and most favored route for drug administration so oral controlled release of drugs becomes a very promising approach for drugs that having the shorter half-life and high dose frequency. Matrix tablets are an interesting option and new break through when developing an oral controlled release drugs delivery system. The use of various classes of release rate retardants like hydrophilic, hydrophobic, polymers and their degradation products are focused also. Release of drugs from matrices formulated with hydrophobic polymers is slower than from matrices formulated with hydrophilic Polymers.

The present article contains a brief review of various formulation approaches used in controlled release drug delivery systems, the role of polymers in the controlled delivery of many fast release drugs and the mechanism of drug release from these polymeric matrices. The oral controlled release system of many drugs has been known to be an essential part of formulation development in drug delivery systems. It has been the focus of pharmaceutical research for many years due to its various advantages over conventional dosage forms. Administering the drug for release in the blood at a controlled rate, to maintain relatively constant drug levels in plasma over a controlled period of time, can overcome many problems associated with conventional dosage forms. The applicability of these dosage forms is due to reduction in the frequencies of drug dosing, which lead to patient convenience and compliance. In addition, a reduction of wide fluctuations in plasma drug concentration peak can be obtained. As a result, toxicity and poor efficacy can be avoided, especially with drugs of narrow therapeutic indices. Such problems, associated with conventional dosage forms of many drugs, can be overcome by using controlled release drug delivery systems, to deliver the drug for absorption at a controlled rate over an extended period of time. The controlled release dosage form should be tailored so that variations in the components can lead to predictable alterations in the drug release profiles. Various controlled release drug delivery systems have different mechanisms to control the drug release rate, such as the osmotic pump, ion exchange resin and matrix systems which have been widely utilized as controlled release drug delivery approaches. Besides, polymers have often been used in the components of controlled release drug delivery systems.

Keywords

Introduction Matrix Tablet, Hydrophobic Polymer, Hydrophilic Polymer, Controlled Release Matrix System.

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Smita S. Aher ¹, Poonam R. Songire ², Ravindra B. Saudagar ¹

Affiliations
1 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, IN
2 Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, IN

Abstract

A sustained release matrix formulation for Albuterol Sulphate was designed and developed to achieve a 12 h release profile. Using HPMC K15M and HPMC K100M as an inert matrix forming agent to control the release of Albuterol Sulphate. The matrix tablets for these formulations were prepared by direct compression and their in-vitro release tests were carried out for a period of 12 hours using USP dissolution test apparatus (type II Paddle) at 37±0.5°C and 50 rpm speed. A 3² full factorial design was used for optimization by taking the concentration of HPMC K15M (X1) and HPMC K100M (X2) were selected as independent variables, whereas initial release at the (Y1, % drug release), (Y2, % drug Content) the concentration of Were chosen as dependent variables. The optimized formulation F9 follows Higuchi model and Korsemeyer - Pappas release kinetics with non- Fickian diffusion mechanism. From the study, it was concluded that the release of Albuterol Sulphate can be effectively controlled using combination of HPMC K15M, HPMC K 100M and Carbopol 940.

Keywords

Albuterol Sulphate, Gelucire43/01, Melt Method, Direct Compression Method, Factorial Design.

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Poonam R. Songire ¹, Smita Aher ², Dipti Phadtare ², R. B. Saudagar ²

Affiliations
1 Department of Quality Assurance Technique, R.G. Sapkal college of Pharmacy, Anjaneri, Nashik, Maharashtra, IN
2 Department of Pharmaceutical Chemistry, R. G. Sapkal College of Pharmacy, Anjaneri, Nashik, Maharashtra, IN

Abstract

Abstract are related to the elemental impurities it included identification, structural elucidation and quantitative determination of impurities. It included According to ICH guidelines, Impurities associated with APIs are classified into the categories. In elemental impurities Four-step process to assess and control elemental impurities in the drug product. Identification of impurities is done by variety of Chromatographic and Spectroscopic techniques, either alone or in combination with other techniques. These impurities are control with strategy.

Keywords

Elemental Impurities, Types of Impurities, Control Strategy.

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