A Review Article on Dissolution Studies in Novel Drug Delivery System (original) (raw)
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DISSOLUTION RESEARCH: ON ITS APPARATUS AND KINETIC MODEL'S OF DRUG RELEASE PROFILE
A dissolution process started too developed about 100 years ago as a field of pharmacy and since then important progress has been made. In its drug related dissolution has grown, since there is a realized that dissolution has an important factor of drug bioavailability in the 1950s.The most important development in the area, from a historical point of view. This review article on Dissolution apparatus and history as pharmacopoeia. Dissolution testing methods and kinetic model for conventional and novel pharmaceutical dosage forms. Apart from dissolution data act as marker for bioavailability and it's a wide variety of application. Those various dissolution apparatus along with dissolution models will be helpful in predicting drug release kinetics (dissolution kinetics).
A key approach on dissolution of pharmaceutical dosage forms
2017
Dissolution testing is a critical methodology which is widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium, allowing it to dissolve over a specified period of time and then assaying the resultant solution using appropriate analytical method to determine the amount of drug. Dissolution tests are relevant for an array of investigations like drug degradation profiles, stability and shelf life studies, physical and mechanical testing of dosage forms, incoming QC testing on raw materials etc. The present review outlines the recent findings on various dissolution apparatuses, their modifications, methods for degassing of media like Helium sparging, Heating and filtering, Vacuum degassing, sonication and dissolution testing of various dosage forms like Immediate Release (IR) Dosage forms, Delayed Release Dosage Forms, Extended Release Dosage ...
Dissolution-A Quality Parameter for Testing of Pharmaceutical Dosage Form D Review
2020
In the pharmaceutical industry, dissolution study is one of the vital tests for the evaluation of the pharmaceutical dosage form. Dissolution test is the most important tool for the testing of drug release profile of solid dosage form in the pharmaceutical preparation. Dissolution studies provide the knowledge about the efficacy of the dosage form. Dissolution tests are major for performing a various kind of investigations like drug degradation profiles, stability and shelf life studies, chemical stability and so on. Dissolution test can be easily performed in both the small and large scale with the proper techniques and it is also used for the comparison between the graph profile of the similar and different dosage form. Hence, it can be considered as the most qualitative and convenient test for the evaluation of the pharmaceutical solid dosage form.
FARMACIA, 2018
The current paper represents the continuation of a previous report focusing on the role of in vitro dissolution testing in the estimation of the in vivo performance for immediate release solid oral dosage forms containing a BCS class 3 drug, metformin hydrochloride. The methodology was extended by application of alternative compendial apparatuses (flowthrough cells and reciprocating cylinders, using basket or paddle method as reference) and testing of a higher strength (850 mg). The experimental results suggested the complementarity of information generated by different hydrodynamic parameters and volumes of media. Rezumat Prezenta lucrare reprezintă continuarea unui raport anterior asupra rolului testelor de dizolvare in vitro în estimarea performanței in vivo a formelor farmaceutice solide orale conținând o substanță medicamentoasă din clasa 3 BCS, metformin clorhidrat. Metodologia a fost extinsă prin aplicarea unor aparate compendiale alternative (celulele în flux continuu și cilindri cu mișcări alternative, utilizând metodele cu paletă sau coșuleț ca referință) și testarea unei doze mai mari (850 mg). Rezultatele experimentale au sugerat complementaritatea informației generate de parametri hidrodinamici și volume de mediu diferite.
Dissolution Technologies
In vitro dissolution testing can serve as an effective and efficient tool for evaluating the influence of formulation and manufacturing variables on drug release characteristics. The targeted purpose will determine the method used and the implications of the test results. Regardless of its intended purpose, it is necessary to understand the factors influencing in vitro dissolution outcomes to avoid the introduction of error into the data interpretation. This will influence the selection of the in vitro test procedure, ensuring that the method can identify changes in the critical formulation and manufacturing variables. There is also a need to understand the rate limiting factors influencing in vivo product bioavailability both from a dissolution and an absorption perspective. Finally, to achieve in vivo biorelevance, it is necessary to understand how the selected in vitro dissolution test method reflects the variables impacting in vivo product dissolution behavior. This primer summarizes and integrates these diverse variables, fostering an appreciation of the strengths and potential pitfalls that may be encountered during the generation and analysis of in vitro dissolution profiles associated with oral dosage forms. This understanding is needed for developing a well-designed dissolution test procedure that is appropriately fit for purpose.
Journal of Controlled Release, 1998
Dissolution testing is an essential requirement for the development, establishment of in vitro dissolution and in vivo performance (IVIVR), registration and quality control of solid oral dosage forms. The objective of the present study was to investigate the effect of delivery system positioning in accordance with the USP 23-recommended dissolution methods and the proposed modification on drug release from controlled release systems having different operating release mechanisms, namely, swellable floatable, swellable sticking and osmotic pump. The delivery systems were evaluated by placing each dosage form either in the dissolution vessel in accordance with the USP 23 methods or over / below a designed ring / mesh device for achieving full surface exposure to the dissolution medium for sticking or floatable systems respectively. Results indicate that the overall release profiles from the sticking and floatable systems of theophylline are sensitive to their positioning in the dissolution vessel (P,0.05). Furthermore, release of diltiazem hydrochloride from the sticking system also demonstrated sensitivity (P,0.05). In contrast, the floatable dosage form of this latter drug with the application of a helical wire sinker, or when it was placed below the ring / mesh assembly, or by allowing the dosage form to float, did not show sensitivity (P.0.05) for the overall release behavior. This was attributed to the greater solubility of diltiazem hydrochloride (50% solubility in water at 258C) in comparison to theophylline which is a sparingly soluble drug (0.85% solubility in water at 258C). Drug release from the osmotic pump appeared to be identical under the given experimental conditions (P.0.05). Statistical analysis of data was performed by comparing the t , t , t ; mean dissolution times (MDT , MDT , 50% 70% 90% 50% 70% MDT); the ''difference factor, f '' and ''similarity factor, f ''. It is concluded that the results derived from the application 90% 1 2 of the ''similarity factor, f '' are superior to the individual time points (e.g. t %) and MDT % values in differentiating 2 x x between overall release patterns or the border line release profile differences. It also became apparent that in the case of the swellable sticking systems full surface exposure to the dissolution medium results in greater release rate. For the osmotic pump the required osmotic pressure threshold necessary for constant rate drug delivery appears to have reached independent of the hydrodynamic conditions. A successful and more accurate evaluation of dissolution data can be derived when full surface exposure is considered and this can be accomplished by dissolution method modification with the aid of the designed ring / mesh assembly.
Dissolution Technologies
Intrinsic dissolution testing has been applied for characterization of pure API with respect to its dissolution behavior. The effect of formulation factors and processing parameters on dissolution rate is evaluated by dissolution testing of the final product, which is a time and resource-consuming process. Our objective was to use intrinsic dissolution testing for determining the effect of processing parameters on drug release. In the present study, an intrinsic dissolution testing method was developed for atenolol and validated according to the standard guidelines using USP-recommended dissolution media. Various experimental variables (compaction pressure and rotation speed of the disk) were optimized by studying at three levels. Atenolol was subjected to granulation in a super mixer granulator by applying standard wet granulation protocols. Granulation time and binder concentration were taken as process variables while dissolution rate was a response variable. Dissolution media had no interference with sample analysis, and all validation parameters for the developed method were in an acceptable range (%RSD > 1). The intrinsic dissolution rate of atenolol (1.84 ± 0.13 mg/cm 2 min) was high due to its better solubility in dissolution media. The dissolution rate of atenolol was decreased by granulating with PVP under different conditions. We concluded that intrinsic dissolution testing method can be applied for determining the effect of processing parameters on dissolution rate of the API at the pre-compression level. This method will reduce experimentation for optimization of dissolution rate and will spare time and resources.