Evaluation of USP apparatus 3 for dissolution testing of immediate-release products

With the purpose of evaluating the behavior of different polymers employed as binders in small-diameter pellets for oral administration, we prepared formulations containing paracetamol and one of the following polymers: PVP, PEG 1500, hydroxypropylmethylcellulose and methylcellulose, and we evaluated their different binding properties. The pellets were obtained by the extrusion/spheronization process and were subsequently subjected to fluid bed drying. In order to assess drug delivery, the United States Pharmacopeia (USP) apparatus 3 (Bio-Dis) was employed, in conjunction with the method described by the same pharmacopeia for the dissolution of paracetamol tablets (apparatus 1). The pellets were also evaluated for granulometry, friability, true density and drug content. The results indicate that the different binders used are capable of affecting production in different ways, and some of the physicochemical characteristics of the pellets, as well as the dissolution test, revealed that the formulations acted like immediate-release products. The pellets obtained presented favorable release characteristics for orally disintegrating tablets. USP apparatus 3 seems to be more adequate for discriminating among formulations than the basket method.

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New Approach for the Application of USP Apparatus 3 in Dissolution Tests: Case Studies of Three Antihypertensive Immediate-Release Tablets

AAPS PharmSciTech ◽

10.1208/s12249-018-1086-0 ◽

2018 ◽

Vol 19 (7) ◽

pp. 2866-2874 ◽

Cited By ~ 1

Author(s):

Brenda Espíndola ◽

Francieli Furlan Bortolon ◽

Juliana Munari Oliveira Pinto ◽

Bianca Ramos Pezzini ◽

Hellen Karine Stulzer

Keyword(s):

Case Studies ◽

Immediate Release ◽

New Approach ◽

Dissolution Tests ◽

Apparatus 3 ◽

Usp Apparatus

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The Effect of Different Superdisintegrants and their Concentrations on the Dissolution of Topiramate Immediate Release Tablets

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2009.2.2.6 ◽

2009 ◽

Vol 2 (2) ◽

pp. 531-5366

Author(s):

V A. Vamshi Priya ◽

G. Chandra Sekhara Rao ◽

D. Srinivas Reddy ◽

V. Prabhakar Reddy

Keyword(s):

Immediate Release ◽

Drug Dissolution ◽

Dissolution Profile ◽

Dissolution Medium ◽

Lactose Monohydrate ◽

Sodium Starch Glycolate ◽

Tablet Disintegration ◽

Croscarmellose Sodium ◽

Model Drug ◽

Usp Apparatus

The purpose of this study was to investigate the efficiency of superdisintegrants: sodium starch glycolate, croscarmellose sodium and crospovidone in promoting tablet disintegration and drug dissolution of Topiramate immediate release tablets. The efficiency of superdisintegrants was tested, by considering four concentrations, viz., like 2%, 3%, 4% and 5% in the formulations. The dissolution was carried out in USP apparatus II at 50 rpm with distilled water as a dissolution medium. The dissolution rate of the model drug topiramate was found highly dependent on the tablet disintegration, on the particle size of the superdisintegrant, on the solubility of the drug and also on the type of superdisintegrant in the dissolution medium. There was no effect of the diluent (Lactose monohydrate) on the disintegration of different concentrations of superdisintegrants. These results suggest that, as determined by the f2 metric (similarity factor), the dissolution profile of the formulation containing 4% sodium starch glycolate and lactose monohydrate as a diluent was similar to that of a marketed product.

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Dissolution Testing of Nicotine Release from OTDN Pouches: Product Characterization and Product-to-Product Comparison

Separations ◽

10.3390/separations8010007 ◽

2021 ◽

Vol 8 (1) ◽

pp. 7

Author(s):

Fadi Aldeek ◽

Nicholas McCutcheon ◽

Cameron Smith ◽

John H. Miller ◽

Timothy L. Danielson

Keyword(s):

In Vitro Release ◽

Product Category ◽

Immediate Release ◽

Tobacco Product ◽

Oral Dosage ◽

Dissolution Testing ◽

Release Rates ◽

Usp 4 ◽

Release Profiles

In recent years, oral tobacco-derived nicotine (OTDN) pouches have emerged as a new oral tobacco product category. They are available in a variety of flavors and do not contain cut or ground tobacco leaf. The on!® nicotine pouches fall within this category of OTDN products and are currently marketed in seven (7) flavors with five (5) different nicotine levels. Evaluation of the nicotine release from these products is valuable for product assessment and product-to-product comparisons. In this work, we characterized the in vitro release profiles of nicotine from the 35 varieties of on!® nicotine pouches using a fit-for-purpose dissolution method, employing the U.S. Pharmacopeia flow-through cell dissolution apparatus 4 (USP-4). The nicotine release profiles were compared using the FDA’s Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. The cumulative release profiles of nicotine show a dose dependent response for all nicotine levels. The on!® nicotine pouches exhibit equivalent percent nicotine release rates for each flavor variant across all nicotine levels. Furthermore, the nicotine release profiles from on!® nicotine pouches were compared to a variety of other commercially available OTDN pouches and traditional pouched smokeless tobacco products. The percent nicotine release rates were found to be dependent on the product characteristics, showing similarities and differences in the nicotine release profiles between the on!® nicotine pouches and other compared products.

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Automatic Dissolution Testing with High-Temporal Resolution for Both Immediate-Release and Fixed-Combination Drug Tablets

Scientific Reports ◽

10.1038/s41598-019-53750-w ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 2

Author(s):

Zhongmei Chi ◽

Irfan Azhar ◽

Habib Khan ◽

Li Yang ◽

Yunxiang Feng

Keyword(s):

High Speed ◽

Sequential Analysis ◽

Immediate Release ◽

Drug Dissolution ◽

High Temporal Resolution ◽

Dissolution Profile ◽

Dissolution Testing ◽

Combination Drug ◽

Efficient Separation ◽

High Efficient

AbstractDissolution testing plays many important roles throughout the pharmaceutical industry, from the research and development of drug products to the control and evaluation of drug quality. However, it is a challenging task to perform both high-efficient separation and high-temporal detection to achieve accurate dissolution profile of each active ingredient dissolved from a drug tablet. In our study, we report a novel non-manual-operation method for performing the automatic dissolution testing of drug tablets, by combining a program-controlled sequential analysis and high-speed capillary electrophoresis for efficient separation of active ingredients. The feasibility of the method for dissolution testing of real drug tablets as well as the performance of the proposed system has been demonstrated. The accuracy of drug dissolution testing is ensured by the excellent repeatability of the sequential analysis, as well as the similarity of the evaluation of dissolution testing. Our study show that the proposed method is capable to achieve simultaneous dissolution testing of multiple ingredients, and the matrix interferences can be avoided. Therefore it is of potential valuable applications in various fields of pharmaceutical research and drug regulation.

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Level A IVIVC for immediate release tablets confirms in vivo predictive dissolution testing for ibuprofen

International Journal of Pharmaceutics ◽

10.1016/j.ijpharm.2021.121415 ◽

2021 ◽

pp. 121415

Author(s):

I Cámara-Martinez ◽

J.A. Blechar ◽

A. Ruiz-Picazo ◽

A. Garcia-Arieta ◽

C. Calandria ◽

...

Keyword(s):

Immediate Release ◽

Dissolution Testing

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Effect of Sodium Starch Glycolate on Formulation of Fexofenadine Hydrochloride Immediate Release Tablets by Direct Compression Method

Journal of Scientific Research ◽

10.3329/jsr.v10i1.32703 ◽

2018 ◽

Vol 10 (1) ◽

pp. 31-38 ◽

Cited By ~ 2

Author(s):

S. Karim ◽

A. Biswas ◽

A. Bosu ◽

F. R. Laboni ◽

A. S. Julie ◽

...

Keyword(s):

Immediate Release ◽

Direct Compression ◽

Compression Method ◽

Release Formulation ◽

The Core ◽

Sodium Starch Glycolate ◽

Zero Order Kinetics ◽

Speed Up ◽

Usp Apparatus ◽

Paddle Apparatus

Present study aspires at the design of an immediate release formulation with prospective use of fexofenadine hydrochloride by exploring the effect of sodium starch glycolate as super disintegrant. Fexofenadine hydrochloride immediate release tablets (Formulations F-1, F-2, F-3, F-4 and F-5) using different ratios of sodium starch glycolate as a disintegrant were prepared by direct compression method. Standard physicochemical tests were performed for all the formulations. Dissolution studies of the formulations were done in phosphate buffer, pH 6.8 using USP apparatus II (paddle apparatus) at 50 rpm. Percent release of fexofenadine hydrochloride of formulations F-1, F-2, F-3, F-4 and F-5 were 89.98%, 90.98%, 92.95, 96.92% and 99.85%, respectively after 1 h and the release pattern followed the zero order kinetics. The release rate in the formulation F-5 was higher compared to other formulations and the studied market products. Sodium starch glycolate speed up the release of the drug from the core tablets, and the release of fexofenadine hydrochloride from tablets was directly proportional to the amount of sodium starch glycolate present in the formulations and there by produced immediate action.

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COMPARATIVE IN VITRO DISSOLUTION STUDY ON METFORMIN MARKET PRODUCTS USING DIFFERENT DISSOLUTION APPARATUSES

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2019v11i9.34711 ◽

2019 ◽

pp. 65-72

Author(s):

HANAN M. HASHEM ◽

AYA R. ABDOU ◽

NADIA M. MURSI ◽

LAILA H. EMARA

Keyword(s):

Reference Product ◽

Immediate Release ◽

In Vitro Dissolution ◽

Metformin Hydrochloride ◽

Innovator Product ◽

Similarity Factor ◽

Generic Products ◽

Dissolution Efficiency ◽

Usp Apparatus

Objective: This study was proposed to evaluate and compare the in vitro dissolution profiles of six Metformin Hydrochloride (MH) market products. Methods: Different dissolution apparatuses (USP apparatus II, IV and beaker method) were used to evaluate the dissolution profiles (in phosphate buffer, pH 6.8) of two immediate release (IR) generic products of Metformin Hydrochloride (MH): Cidophage® 1000 mg (G1, Egyptian market) and Metformin arrow® 1000 mg (G2, French market) with respect to the reference products named Glucophage® 850 mg (R1, Egyptian market and R2, French market). In addition to a generic controlled-release (CR) product; Cidophage Retard® 850 mg (G3) versus the reference product; Glucophage XR® 1000 mg (R3) (both from Egyptian market). Dissolution efficiency (D. E.) and the similarity factor (f2) were calculated. Weight uniformity, hardness, tablet dimensions and MH content were measured. Results: Results of the three apparatuses showed that MH IR products studied (reference and generics) did not meet the 75% USP 30 specifications for MH dissolved at 30 min. For MH CR products, Glucophage XR® did not fulfill the USP release criteria, while Cidophage Retard® did. USP apparatus IV revealed the highest sensitivity and discriminative capability. Conclusion: Generally, MH IR generics (G1 and G2) might be interchangeable with the innovator product (Glucophage®). However, Cidophage Retard® might not be interchangeable with Glucophage XR®.

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