The characteristics of novel dosage forms

2003 ◽  
Vol 57 (10) ◽  
pp. 424-436 ◽  
Author(s):  
Jela Milic-Askrabic ◽  
Slobodan Petrovic
Keyword(s):  
Drug Delivery ◽  
Active Substance ◽  
Dosage Form ◽  
Technological Development ◽  
Drug Carriers ◽  
Drug Dosage ◽  
Primary Objective ◽  
Material Development ◽  
Conventional Drug ◽  
Drug Dosage Form

The objective of pharmaceutical-technological development is to find a procedure of transforming an active substance (a drug) into a drug dosage form which is not only acceptable for application, but also enables the active substance to be released following administration, pursuant to therapy objectives. The aim is that the concentration of the active substance in the action location rapidly reaches a therapeutic level and maintains an approximately constant level in the course of a particular time, according to the established therapeutic goal. The primary objective is to present the active ingredient (drug) in the form and concentration/quantity that enables the corresponding therapeutic response, i.e. to control the site and rate of medicinal substance release from the drug, as well as the rate at which it reaches the membranes and surfaces to which it is absorbed, while applying a common method of administration. The procedures used to achieve this goal are becoming highly complex and demanding and are aiming at sophisticated drug delivery systems and functional packaging material. Development from the existing drug molecule, through the conventional drug dosage form, to a new system of drug "delivery" (novel delivery system), can improve the drug (active substance) characteristics significantly in view of compliance (acceptability by the patient), safety and efficiency. The paper presents an overview of the most important examples of pharmaceutical forms with controlled release and advanced drug "carriers".

scholarly journals Development and validation of aranosa assay in the dosage form

2018 ◽  
Vol 17 (2) ◽  
pp. 57-62 ◽  
Author(s):  
Z. S. Shprakh ◽  
E. V. Ignаteva ◽  
I. V. Yartseva
Keyword(s):  
Quantitative Determination ◽  
Spectrophotometric Determination ◽  
Active Substance ◽  
Dosage Form ◽  
Sorbic Acid ◽  
Drug Dosage ◽  
Acid Method ◽  
Drug Dosage Form ◽  
Development And Validation

Background. Aranosa, a drug of nitrosoalkylureas class, was developed and studied at N.N. Blokhin NMRCO, Russia, and at present it is produced by N.N. Blokhin NMRСO branch “Naukoprofi”. One of the stages of the drug standardization is the development of an assay technique for quantitative determination of active substance in the final drug dosage form.Objective. Development and validation of an assay for quantitative determination of Aranosa in the dosage form.Materials and methods. The study used “Aranosa, lyophilisate for solution for injection 0.5 g”; Аranosa, substance-powder (N.N. Blokhin NMRCO branch “Naukoprofi”); polyvinylpyrrolidone low-molecular medical; sorbic acid. Method: spectrophotometry. Results. An assay was developed for quantitative spectrophotometric determination of Aranosa in the dosage form “Aranosa, lyophilisate for solution for injection 0.5 g”. Validation was performed to prove reliability and accuracy of the obtained results. The assay was evaluated by validation characteristics, such as specificity, linearity, trueness, precision.Conclusions. The developed assay is provided with trueness, repeatability, precision, and linearity and can be used in the range of 80– 120 % of nominal Aranosa content in the dosage form.

scholarly journals A Mini Review on Mucoadhesion

2020 ◽  
Vol 11 (3) ◽  
pp. 3521-3527
Author(s):  
Gnanasekaran John Selvaraj ◽  
Arul Balasubramanian ◽  
Kothai Ramalingam
Keyword(s):  
Drug Delivery ◽  
Delivery System ◽  
Drug Delivery Systems ◽  
Dosage Form ◽  
Drug Dosage ◽  
Dosage Forms ◽  
Delivery Systems ◽  
Application Site ◽  
Epithelial Surface ◽  
Drug Dosage Form

The concept of mucoadhesion was started in early 1980’s with the aim of controlled delivery of drugs. Mucoadhesion is simply defined as the adhesion between two materials, in which one is the mucosal surface and the another one is the mucoadhesive dosage form. In the recent decades, mucoadhesive drug delivery system draw the attention in the gastroretentive delivery system. Mucoadhesive drug delivery systems interact with the mucus layer covering the mucosal epithelial surface, and mucin molecules and increase the residence time. Mucoadhesive dosage forms are designed to increase the retention of the drug/dosage form at the application site, to provide a controlled release of drug for increased curative consequence. The medications which have local action or those which have maximum absorption in gastrointestinal tract require increased duration of stay in GIT. Mucoadhesive drug delivery systems were prepared by using either natural or synthetic polymers, which is interacting with the mucous layer and used to prevail over the physiological barriers for extended drug delivery. The mucoadhesive ability of a dosage form is depending upon variety of factors, such as the nature of the mucosal tissue and the physicochemical properties of the polymeric formulation. This review article aims to provide an overview of the various theories of mucoadhesion, properties of mucoadhesive materials, methods to study the mucoadhesion, and finally various mucoadhesive dosage forms.

scholarly journals “Success Depends on Your Backbone”—About the Use of Polymers as Essential Materials Forming Orodispersible Films

Materials ◽  
2021 ◽  
Vol 14 (17) ◽  
pp. 4872
Author(s):  
Katarzyna Olechno ◽  
Anna Basa ◽  
Katarzyna Winnicka
Keyword(s):  
Drug Delivery ◽  
Dosage Form ◽  
Geriatric Patients ◽  
Drug Dosage ◽  
Synthetic Polymers ◽  
Disintegration Time ◽  
Orodispersible Films ◽  
Pharmaceutical Technology ◽  
Drug Dosage Form ◽  
Novel Drug

Polymers constitute a group of materials having a wide-ranging impact on modern pharmaceutical technology. Polymeric components provide the foundation for the advancement of novel drug delivery platforms, inter alia orodispersible films. Orodispersible films are thin, polymeric scraps intended to dissolve quickly when put on the tongue, allowing them to be easily swallowed without the necessity of drinking water, thus eliminating the risk of choking, which is of great importance in the case of pediatric and geriatric patients. Polymers are essential excipients in designing orodispersible films, as they constitute the backbone of these drug dosage form. The type of polymer is of significant importance in obtaining the formulation of the desired quality. The polymers employed to produce orodispersible films must meet particular requirements due to their oral administration and have to provide adequate surface texture, film thickness, mechanical attributes, tensile and folding strength as well as relevant disintegration time and drug release to obtain the final product characterized by optimal pharmaceutical features. A variety of natural and synthetic polymers currently utilized in manufacturing of orodispersible films might be used alone or in a blend. The goal of the present manuscript was to present a review about polymers utilized in designing oral-dissolving films.

Spectrophotometric Methods for Simultaneous Determination of Sofosbuvir and Ledipasvir (HARVONI Tablet): Comparative Study with Two Generic Products

2017 ◽  
Vol 100 (4) ◽  
pp. 976-984 ◽  
Author(s):  
Nisreen F Abo-Talib ◽  
Mohamed R El-Ghobashy ◽  
Marwa H Tammam
Keyword(s):  
Dosage Form ◽  
Drug Dosage ◽  
Spectrophotometric Methods ◽  
Accuracy And Precision ◽  
Significant Difference ◽  
Drug Dosage Form ◽  
Generic Products ◽  
Third Derivative ◽  
Combination Pill

Abstract Sofosbuvir and ledipasvir are the first drugs in a combination pill to treat chronic hepatitis C virus. Simple, sensitive, and rapid spectrophotometric methods are presented for the determination of sofosbuvir and ledipasvir in their combined dosage form. These methods were based on direct measurement of ledipasvir at 333 nm (due to the lack of interference of sofosbuvir) over a concentration range of 4.0–14.0 µg/mL, with a mean recovery of 100.78 ± 0.64%. Sofosbuvir was determined, without prior separation, by third-derivative values at 281 nm; derivative ratio values at 265.8 nm utilizing 5.0 µg/mL ledipasvir as a divisor; the ratio difference method using values at 270 and 250 nm using 5.0 µg/mL ledipasvir as a divisor; and the ratio subtraction method using values at 261 nm. These methods were found to be linear for sofosbuvir over a concentration range of 5.0–35.0 µg/mL. The suggested methods were validated according to International Conference on Harmonization guidelines. Statistical analysis of the results showed no significant difference between the proposed methods and the manufacturer's LC method of determination with respect to accuracy and precision. These methods were used to compare the equivalence of an innovator drug dosage form and two generic drug dosage forms of the same strength.

scholarly journals ANALISIS KINETIKA PELEPASAN TEOFILIN DARI GRANUL MATRIKS KITOSAN

2017 ◽  
Vol 2 (1) ◽  
pp. 70
Author(s):  
Suprianto Suprianto
Keyword(s):  
Drug Release ◽  
Dosage Form ◽  
Release Kinetics ◽  
Drug Dosage ◽  
Zero Order ◽  
Information Analysis ◽  
Mathematical Concepts ◽  
First Order ◽  
Drug Dosage Form ◽  
Form Development

Moment the drug dosage form development, it is important to study the drug release or dissolution that is recognized as an element in drug development. Mathematical models could help optimize the design of drugs to produce models of drug release information. Analysis of quantitative values obtained when depicting dissolution drug release profiles more easily when the mathematical concepts used to describe the drug release kinetics model. Model release of drugs known include zero order, first order, Higuchi models, models Hixon Crowell and Peppas Korsmeyer models. The purpose of this review apply mathematical concepts to study the phenomenon of drug release theophylline granules matrix made from chitosan

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