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

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.

A Mini Review on Mucoadhesion

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.

P08 Is there a difference in the frequency of manipulated orally and rectally administered medicines to paediatric in-patients in Sweden in the year 2009 and 2018 respectively? A register study

BackgroundSince there is a lack of drugs in suitable strengths and child-friendly dosage forms, manipulation is sometimes necessary in paediatrics. A manipulation is the physical alteration of a drug dosage form with the purpose to extract and administer the prescribed proportion of a drug dose.The purpose of this study was to calculate the frequency of manipulated medicines administered to paediatric in-patients at a large Children´s Hospital for two separate years and compare whether there has been a change in practice.Material and MethodsData were collected for all administered doses during 2 separate years (2009 and 2018) at the paediatric wards at our Children´s Hospital, from a hospital-based electronic register. All administered doses where the number of tablets or suppositories were decimal were added and calculated as a percentage of the total number of oral and rectal administrations. Data are anonymous but information regarding gender, age, hospital ward and number of drugs per patient were available and were analysed.ResultsIn one year, approximately 450 000 doses of medicine are administered to paediatric patients in our Children´s hospital.The results will be analysed with regards to differences between patient age, gender, prescribing year and drug substance. A pilot study showed that 10% of all solid oral administrations to patients 6 - 12 years old, were part of a tablet. For patients 0 - 2 years over 20% of all solid rectal administrations were part of a suppository.The extent of manipulation is affected by a lot of factors, where the most prominent is whether there are strengths suitable for that age-group available on the market or not.ConclusionMost often there is a lack of knowledge how manipulation of medicines influences the dosing accuracy and often we do this to our most vulnerable patients.Disclosure(s)Nothing to disclose

SOLID DISPERSIONS: A METHOD TO IMPROVE BIOAVAILABILITY OF ORAL DRUG DOSAGE FORM

Presently only few percent of drugs having high aqueous solubility, Number of drugs are belonging to biopharmaceutical classification system class II that means possessing poor aqueous solubility eventually results in low level of drug in systemic circulation. To overcome this problem, various strategies have been come out into notion such as self emulsifying drug delivery system solid dispersions, use of surface active agents, complex formation. Solid dispersions is found to be promising approach to increase bioavailability by use of various polymers. This review focuses on the mechanism of drug release from solid dispersion with its method of preparation and applications. Key words: dissolution, particle size, solid dispersion

Review: Metode Peningkatan Kecepatan Disolusi Dikombinasi Dengan Penambahan Surfaktan

Dissolution and solubility rates are very important parameters in designing a pharmaceutical dosage form, especially for oral drug administration. Oral drugs that have low dissolution rates often require high doses loading to improve the absorption and effectiveness in order to achieve therapeutic concentration. The increasing of drug dose is a less safe alternative solution, therefore researchers have developed physics, chemistry, and other modification in order to increase dissolution rate. These methods such as salt formation, prodrug formation, particle size reduction (micro-crystallization), co-grinding, crystal modification, micellar solubilization and complex formation, solid dispersion and self emulsifying. This review paper will focus on different methods that will be compared with the present of surfactant in these methods. The present of surfactants was able to overcome the limitation of each methods with a mechanism for reducing surface tension, micellar formation, reducing contact angle and increasing of wetting behaviour. Therefore, the present of surfactant in modification of drug dosage form could be considered to increase dissolution rate in order to achieve therapeutic effect.

Development and validation of aranosa assay in the dosage form

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.

Pharmaceutical Cocrystals as an Opportunity to Modify Drug Properties: From the Idea to Application: A Review

The properties of many drugs which have been available on the pharmaceutical market for a long time still need to be improved. Cocrystals are the solid state drug modification which can improve properties such as low solubility, stability and mechanical properties (e.g. compressibility). In this paper, examples of how to use cocrystals to modify properties of API (Active Pharmaceutical Ingredient) will be reported. Additionally, in this review, the way from an idea of the new cocrystal to drug dosage form registration will be shortly described.

Evaluation of capsule labelling for its wall contents as gelatin or non gelatin

Background: Capsules are the most commonly used solid drug dosage form and are made up of gelatin or non gelatin. Currently the gelatin based capsules drug formulations are more used. However, current issue of vegetarian and non vegetarian capsules has come up due to recent Indian government initiative to promote vegetarian capsules.Methods: There were 100 capsule dosage forms were examined for the gelatin or HPMC wall contents and nature of medicine contained in capsules, whether ayurvedic or allopathic.Results: Out of 100 capsules studied 55 had gelatin wall base while 25 had HPMC and 20 capsule labels did not mention the nature of capsule wall constituent. Out of 55 gelatin capsules 30 were of allopathic while 25 capsules were of ayurvedic medicines. Among HPMC, 15 were ayurvedic while 10 allopathic. 20 capsules had no mention of its constituent and among these non labelled capsule formulations had 11 from ayurvedic and 9 from allopathic medicines.Conclusions: The current study revealed that gelatin capsules forms bulk in Indian market. Even the gelatin capsules contained ayurvedic medicines while 10% of HPMC capsules contained allopathic medicines. Non labelled capsules formed 20% of total capsules. These findings suggest wider scope for promotion of HPMC based capsules.