Opadry clear

Q: What specific citation details should I use when referencing Opadry Clear in scientific publications?

When referencing Opadry Clear, include the specific Colorcon product code, such as OC-0X-XXXX, the lot number, and specify the exact formulation variant. Recommended citation format includes manufacturer details, lot tracking information, and precise chemical composition to ensure reproducibility and accurate scientific documentation.

Q: What pharmaceutical systems and processes are compatible with Opadry Clear?

Opadry Clear integrates seamlessly with fluid bed granulators, coating equipment by O'Hara Technologies, and various tablet presses. It demonstrates excellent compatibility with excipients like microcrystalline cellulose, colloidal silicon dioxide, and can be used across multiple manufacturing platforms including Bosch and Servolift equipment.

Q: In what pharmaceutical and research domains is Opadry Clear most frequently utilized?

Opadry Clear is predominantly used in pharmaceutical formulation, specifically for modified-release tablets, immediate-release coatings, and taste-masking applications. Primary research domains include oral solid dosage development, controlled-release drug delivery systems, and pharmaceutical manufacturing process optimization.

Q: What unique scientific innovation is associated with Opadry Clear?

An intriguing aspect of Opadry Clear is its potential in developing novel drug delivery mechanisms, particularly in creating ultra-thin, optically transparent coatings that can modulate drug release kinetics while maintaining exceptional visual clarity and minimal impact on tablet weight and dimensions.

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About the product

Opadry® Clear is a versatile film coating system designed for the pharmaceutical and nutraceutical industries. It is a water-soluble, polymer-based coating that provides a clear, glossy finish to solid oral dosage forms. The primary function of Opadry® Clear is to protect the active ingredient, improve the appearance, and enhance the swallowability of the final product.

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Solutab a ip, by Blanver Farmoquimica (3 mentions) Polyplasdone xl, by Ashland (3 mentions) Sugar spheres 40 60 mesh, by Paulaur (2 mentions) Methocel e5 premium, by Dow (2 mentions) Eudragit l 30d, by Rohm Tech (2 mentions) Imwitor 900, by Rohm Tech (2 mentions) Eudragit fs30d, by Evonik (2 mentions) Povidone, by BASF (1 mentions) Fluid bed granulator, by Bosch (1 mentions) Magnesium stearate, by Mosselman (1 mentions) Partially pregelatinized maize starch, by Colorcon (1 mentions) Calcium carbonate, by Nuoceng Pharmaceuticals (1 mentions) Triethylcitrate, by Colorcon (1 mentions) Balances and scales, by Mettler Toledo (1 mentions) Blendingblender, by Servolift (1 mentions) Oblong punch 18.2 7 7 mm, by O'Hara Technologies (1 mentions) Coatingcoating equipment, by O'Hara Technologies (1 mentions) Acryl eze, by Colorcon (1 mentions) Colloidal silicon dioxide, by Evonik (1 mentions) Microcrystalline cellulose, by JRS Pharma (1 mentions)

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Opadry - 24 citations OPADRY® YS-1-19025-A Clear - 3 citations

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Product FAQ

How does Opadry Clear differentiate itself in the pharmaceutical coating landscape?

Opadry Clear stands out through its exceptional film clarity, superior adhesion properties, and versatility across multiple dosage forms. Unlike alternative coating solutions, it provides a transparent, uniform coating that maintains product aesthetics while ensuring optimal film performance. Competitive products in this market include Eudragit systems by Evonik, HPMC coatings by Dow, and other film coating technologies.

What specific citation details should I use when referencing Opadry Clear in scientific publications?

What pharmaceutical systems and processes are compatible with Opadry Clear?

In what pharmaceutical and research domains is Opadry Clear most frequently utilized?

What unique scientific innovation is associated with Opadry Clear?

11 protocols using «opadry clear»

1

Curcuma longa and Boswellia serrata Phytosome

2022

For the clinical study, the sunflower lecithin-based formulation of Curcuma longa L. and Boswellia serrata standardized extracts (CBP, 500 mg) was prepared by Indena S.p.A., Milan, Italy, as oblong-shaped, film-coated tablets, corresponding to a content of 17.0–23.0% w/w of curcumin and 7.0–11.0% w/w of boswellia extracts, respectively, by high performance liquid chromatography (HPLC) assay [34 (link)]. The active ingredient was a solid dispersion containing the standardized association of curcumin extract (≥90% as total curcuminoids assessed by HPLC assay) and boswellia extract (≥65.0% of total triterpenic acids assessed by HPLC assay). The remaining food-grade components of the phytosome tablets are calcium carbonate E170 (95DC M; Dr Paul Lohman^®, Emmerthal, Germany), polyvinylpolypyrrolidone E1202 (Polyplasdone^™ XL; Ashland, Austria, Germany, United States), sodium croscarmellose E468 (Solutab^® A-IP; Blanver Farmoquimica LTDA, Taboão da Serra, Brasil), silicon dioxide E551 (Syloid^® 244FP; Grace, Columbia), talc E553b (Mondo Minerals B.V., Amsterdam, Netherlands), magnesium stearate E470b (Ligafood^®; Peter Greven, Bad Muenstereifel, Germany), and hydroxypropyl methylcellulose E463-based film-coating (Opadry^® Clear; Colorcon, United Kingdom). Before releasing, the film-coated tablets containing the food-grade lecithin formulation were tested for appearance, average mass, uniformity of mass, HPLC-content of curcumin and boswellia extracts, disintegration time, and microbiological quality.

Giacosa A., Riva A., Petrangolini G., Allegrini P., Fazia T., Bernardinelli L., Peroni G, & Rondanelli M. (2022). Beneficial Effects on Abdominal Bloating with an Innovative Food-Grade Formulation of Curcuma longa and Boswellia serrata Extracts in Subjects with Irritable Bowel Syndrome and Small Bowel Dysbiosis. Nutrients, 14(3), 416.

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2

Bergamot and Artichoke Combination Supplement

2021

For the clinical study, 600 mg of bergamot (Cytrus bergamia polyphenols) phytosome^® and 100 mg of artichoke (Cynara cardunculus L.) leaf standardized dry extract [15 (link)] were formulated by Indena S.p.A. (Milan, Italy) into film-coated tablets containing the following ingredients: dicalcium phosphate dihydrate (Di-Cafos^® D160, Budenheim, Germany), magnesium carbonate (Dr. Paul Lohmann GMBH, Emmerthal, Germany), polyvinylpolypyrrolidone (PolyplasdoneTM XL, Ashland Special Ingredients, Wilmington, DE, USA), sodium croscarmellose (Solutab^® A-IP, Blanver Farmoquimica Ltd., Taboão da Serra, Brazil), silicon dioxide (Syloid^® 244FP, Grace GMBHGmbH, Worms, Germany), talc (Microtalc Pharma 50, Mondo Minerals B.VBV, Amsterdam, The Netherlands), and magnesium stearate (Ligafood^®, Peter Greven, Venlo, The Netherlands). Tablets were coated with a hydroxypropylmethylcellulose-based film coating system (Opadry^® Clear, Colorcon Inc., Indianapolis, IN, USA).
The film-coated tablets were analyzed for appearance, HPLC assay, uniformity of mass, disintegration time, heavy metals, and microbiological quality.
Control is represented by film-coated tablets with the same shape, color, flavor and taste as the intervention tablets.
The supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 2 months (as for a 60-day continuous integration). Compliance to the supplementation regimen was defined as the number of tablets actually taken by each subject divided by the number of tablets that should have been taken over the course of the study. Adverse events (AEs) were based on spontaneous reporting by subjects as well as open-ended inquiries by members of the research staff. Safety was assessed by laboratory tests performed at baseline and end of treatment (EoT) detailed below, and by recording volunteered adverse events.

Riva A., Petrangolini G., Allegrini P., Perna S., Giacosa A., Peroni G., Faliva M.A., Naso M, & Rondanelli M. (2021). Artichoke and Bergamot Phytosome Alliance: A Randomized Double Blind Clinical Trial in Mild Hypercholesterolemia. Nutrients, 14(1), 108.

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3

Tailored Copper Gluconate Enteric Coatings

2021

Example 5

A second dissolution target was established for patients with higher stomach pH levels, e.g., patients undergoing proton pump inhibitor treatment concurrent with chemotherapy. The coated copper gluconate minitablets discussed above were further coated with a coating that dissolves as a function of time (e.g., exhibits pH-independent swelling) to provide additional protection against copper gluconate dissolution in the stomach. Coating studies were performed on copper gluconate minitablets coated with: a) Opadry® (4.5% W.G.) and Eudragit® FS 30 D (12% W.G.); b) Opadry® (4.5% W.G.), Eudragit® FS 30 D (12% W.G.) and Eudragit® RL (2%, 4%, and 6% W.G.). Eudragit® RS 30D and Eudragit® RL 30D are pH-independent polymers. Both Eudragit® RS 30D and RL 30D are composed of ethyl acrylate, methyl methacrylate, and a low content of methacrylic acid ester with quaternary ammonium groups. Eudragit® RL 30D contains more ammonium groups than Eudragit® RS 30D, thus it has faster water permeability than Eudragit® RS 30D.

Minitablets were produced as follows: 2 kg of copper gluconate powder blend was prepared and around 1.4 kg of copper gluconate minitablets was obtained for coating trials after the process of tableting. Due to the low weight variation (>95% of tablets within target weight±7.5%) observed on tablets produced by the tablet press, these minitablets were directly used for coating trials without evaluating weight. The minitablets were first coated with 4.5% weight gain of Opadry® Clear (Colorcon, Calif.) and 12% weight gain of Eudragit® FS30D (Evonik, N.J.). The initial dissolution testing was performed as follows: three coated copper gluconate tablets were put in a size 00 Licaps® gelatin capsule prefilled with four disulfiram tablets (10 mg of disulfiram each). These capsules were then packaged in a 60 cc bottles for stability testing. Results are shown in Table 18.

Minitablets pre-coated with Opadry® Clear 4.5% W.G. and Eudragit® FS30D (12% W.G.) were then further coated with 2%-10% weight gain of Eudragit® RL30D (Evonik, N.J.). Dissolution testing was performed and drug recovery was determined every hour between 1 h and 8 h. The results presented in Table 19 and FIG. 6 show that the additional coating of Eudragit® RL30D of 2,%, 4% or 8% weight gain successfully delayed the release of copper beyond the minitablets coated with Opadry® Clear and 12% weight gain of Eudragit® FS30D alone. In particular, the copper gluconate tablets coated with Eudragit® FS (12% weight gain) and Eudragit® RL (2% weight gain) displayed no copper release in 0.1 N HCL and 91.03% recovery after 3 hours in sodium citrate pH 7.4.

Dissolution testing was also performed on minitablets coated with pH-sensitive coats that exhibit swelling at higher pH. To assess coat combinations that may provide drug recovery at higher pH, copper gluconate minitablets were coated with Opadry® (3% W.G.) and Eudragit® FS 30 D (4% or 6% W.G.), Table 20. Eudragit® FS 30 D is a pH-dependent coating that allows drug release at pH>7. The copper gluconate minitablets coated with Opadry® (3% W.G.) and Eudragit® FS 30 D (4% W.G.) demonstrated 88.18% release of copper after 2 hours in sodium citrate pH 7.4 and 95.43% release of copper after 2.5 hours in sodium citrate pH 7.4. The copper gluconate minitablets coated with Opadry® (3% W.G.) and Eudragit® FS 30 D (6% W.G.) demonstrated 61.02% release of copper after 2 hours in sodium citrate pH 7.4 and 88.48% release of copper after 2.5 hours in sodium citrate pH 7.4 (Tables 20, 21 and FIG. 7).

Further dissolution studies are performed with copper gluconate minitablets coated with 3% Opadry®, 8% Acryl-EZE®, and 2% Eudragit® RL. Copper in the minitablets is intended to be released in small intestine for patients with and without treatment of proton pump inhibitors (PPI)s having a neutral or acidic stomach pH, respectively. Copper release is expected to be slightly earlier in the presence of treatment with PPIs and relatively slower for an acidic stomach. 2% Eudragit® RL coating gives an additional 2-3 hour delay of copper release beyond the 2 hour protection from acid provided by Acryl-EZE® alone. The actual dissolution profile of copper gluconate with 8% Acryl-EZE® and 2% Eudragit® RL should fall into the region between hypothetical curve #1 and #2 (FIGS. 8-11). Dissolution tests are also performed on copper gluconate minitablets coated with 3% Opadry®, 4% Eudragit® FS, and 2% Eudragit® RL. Copper in the minitablets is intended to be released in ileum/colon for patients with and without treatment of PPIs (neutral or acidic stomach pH, respectively). The 2% Eudragit® RL coating gives additional 2-3 hour delay on copper release beyond the 2 hour protection from acid provided by Eudragit® FS alone. The actual dissolution profile of copper gluconate with 4% Eudragit® FS and 2% Eudragit® RL should fall into the region between hypothetical curve #1 and #2 (FIGS. 8-11).

TABLE 18

Dissolution tests on capsules with Copper Gluconate and/or Disulfiram minitablet

coated with Opadry ® (4.5% W.G.) and Eudragit ® FS 30 D (12% W.G.) at Time = 0

% Drug Recovery

Capsule2 h (T0)1 h2.5 h3.5 h

Dissolution testsAPIConfiguration0.1N HClSodium Citrate pH 7.4

Copper gluconate coated withCu3x tablets105.44 ± 0.020%4.44 ± 0.010% 6.67 ± 0.024% 6.96 ± 0.020%

Opadry ® (4.5% W.G.)Gluconate

(coated)

Copper gluconate coated withCu3x tablets 3.22 ± 0.007%4.67 ± 0.003%72.80 ± 0.162%98.70 ± 0.057%

Opadry ® (4.5% W.G.) and Eudragit ®Gluconate

FS 30 D (12% W.G.)(coated)

Copper gluconate coated withCu3x tabletsNPNPNPNP

Opadry ® (4.5% W.G.) and Eudragit ®Gluconate

FS30D (12% W.G.)(coated)

Uncoated disulfiram, 10 mgDisulfiram2 x tablets

(uncoated)

Table 18 Legend:

1. Data are presented as Mean ± SD (N = 3 capsules);

NP: not performed;

2. Normal dissolution testing on Copper Gluconate was performed at 37° C., 50 rpm, and 50 mL of dissolution media (0.1N HCl or Sodium Citrate pH 7.4) per SOP QC-223;

3. Eudragit ® FS 30 D is a pH-dependent enteric polymer used to release the drug at the solution with pH value above 7

TABLE 19

Dissolution tests on capsules with Copper Gluconate and/or Disulfiram minitablet coated with Opadry ® (4.5%

W.G.), Eudragit ® FS 30 D (12% W.G.) and Eudragit ® RL (2%, 4% and 6% W.G.) at Time = 0 (T0)

% Drug Recovery

Eudragit ® RLCapsule1 h2 h2.5 h

Dissolution testscoatingConfigurationSodium Citrate pH 7.4

Copper gluconate coated with0%3x tablets5.2425.8874.49

Opadry ® (4.5% W.G.), and

Eudragit ® FS30D (12% W.G.)

Copper gluconate coated with2%3x tablets4.09 ± 0.834%3.78 ± 0.829%3.93 ± 1.254%

Opadry ® (4.5% W.G.),

Eudragit ® FS30D (12% W.G.),

and Eudragit ® RL30D (2% W.G.)

Copper gluconate coated with4%3x tablets5.06 ± 2.040%3.93 ± 3.219%7.64 ± 0.972%

Opadry ® (4.5% W.G.),

Eudragit ® FS30D (12% W.G.),

and Eudragit ® RL30D (4% W.G.)

Copper gluconate coated with6%3x tablets3.36 ± 0.882%5.07 ± 0.853%5.27 ± 0.136%

Opadry ® (4.5% W.G.),

Eudragit ® FS30D (12% W.G.),

and Eudragit ® RL30D (6% W.G.)

% Drug Recovery

3 h3.5 h4 h8 h

Dissolution testsSodium Citrate pH 7.4

Copper gluconate coated with91.4086.7588.3791.03

Opadry ® (4.5% W.G.), and

Eudragit ® FS30D (12% W.G.)

Copper gluconate coated with3.97 ± 0.138%7.57 ± 6.128%13.77 ± 11.672%91.95 ± 0.635

Opadry ® (4.5% W.G.),

Eudragit ® FS30D (12% W.G.),

and Eudragit ® RL30D (2% W.G.)

Copper gluconate coated with6.43 ± 6.736%12.20 ± 8.758% 9.61 ± 8.837%56.44 ± 9.765%

Opadry ® (4.5% W.G.),

Eudragit ® FS30D (12% W.G.),

and Eudragit ® RL30D (4% W.G.)

Copper gluconate coated with7.22 ± 3.528%4.98 ± 1.590%4.16 ± 0.090%20.39 ± 4.130%

Opadry ® (4.5% W.G.),

Eudragit ® FS30D (12% W.G.),

and Eudragit ® RL30D (6% W.G.)

Table 19 Legend:

1. Data are presented as Mean ± SD (N = 3 capsules);

NP: not performed;

2. Normal dissolution testing on Copper Gluconate was performed at 37° C., 50 rpm, and 50 mL of dissolution media (0.1N HCl or Sodium Citrate pH 7.4;

3. Eudragit ® FS 30 D is a pH-dependent enteric polymer used to release the drug at the solution with pH value above 7

TABLE 20

Dissolution testing on Copper Gluconate micro tablets coated with Opadry ® (3%

W.G.) and Eudragit ® FS 30 D (4 or 6% W.G.) at Time 0 (T0)

% Drug Recovery at T0

Capsule2 h1 h1.5 h2 h

Dissolution testsConfiguration0.1N HClSodium Citrate pH 7.4

Copper gluconate coated3x tablets2.36 ± 1.231%40.37 ± 4.955%74.46 ± 8.048% 88.18 ± 5.851%

with Opadry ® (3%

W.G.), and Eudragit ® FS

30D (4% W.G.)

Copper gluconate coated3x tablets3.60 ± 1.384%19.10 ± 2.463%19.10 ± 13.107%61.02 ± 7.687%

with Opadry ® (3%

W.G.), and Eudragit ® FS

30D (6% W.G.)

% Drug Recovery at T0

2.5 h3 h3.5 h

Dissolution testsSodium Citrate pH 7.4

Copper gluconate coated95.43 ± 5.269%95.44 ± 4.602%100.24 ± 3.864%

with Opadry ® (3%

W.G.), and Eudragit ® FS

30D (4% W.G.)

Copper gluconate coated88.48 ± 4.166%96.23 ± 4.219% 98.95 ± 3.630%

with Opadry ® (3%

W.G.), and Eudragit ® FS

30D (6% W.G.)

Table 20 Legend:

1. W.G.: weight gain;

2. Data are presented as Mean ± SD (N = 3 capsules);

3. Normal dissolution testing on Copper Gluconate was performed at 37° C., 50 rpm, and 50 mL of dissolution media (Sodium Citrate pH 7.4) per SOP QC-223

TABLE 21

Summary of Dissolution tests of Coated Copper Gluconate Tablets

Configuration of TabletDescription of Results

Copper gluconate tablets with Acryl-EZE ®Good protection from acid;

(20% weight gain);Break point of Acryl-EZE ®: pH 5.5 or above;

No release in 0.1N HCl, 80% or above release after 2 h in citrate buffer, pH 6.0

(T0, 1M, 2M, 3M)

Copper gluconate tablets with Eudragit ® RL/RSUnsatisfactory protection from acid;

(8:2 ratio) (2%, 6%, 10% weight gain)2% RL/RS: complete release after 2.5 h of testing;

6% RL/RS: complete release after 3.0 h of testing;

10% RL/RS: 70% release after 3.0 h of testing

Copper gluconate tablets with Eudragit ® FSGood protection from acid;

(12% weight gain);Break point of Eudragit ® FS: pH 7.0 or above;

No release in 0.1N HCl, 80% or above release after 3 h in sod. citrate, pH 7.4

Copper gluconate tablets with Eudragit ® FSNo release in 0.1N HCl, 91.03% drug recovery at the 3 h time point in sod.

(12% weight gain) and Eudragit ® RL (2%citrate, pH 7.4

weight gain)

Copper gluconate tablets with Eudragit ® FSNo release in 0.1N HCl, 56.44% drug recovery at the 3 h time point in sod.

(12% weight gain) and Eudragit ® RL (4%citrate, pH 7.4

weight gain)

Copper gluconate tablets with Eudragit ® FSNo release in 0.1N HCl, 20.39% drug recovery at the 3 h time point in sod.

(12% weight gain) and Eudragit ® RL (6%citrate, pH 7.4

weight gain)

Copper gluconate tablets with Eudragit ® FSNo release in 0.1N HCl, 88.18% drug recovery at the 2 h time point in sod.

(4% weight gain)citrate, pH 7.4

US10905661B2. Disulfiram and metal salt staggered oral dosing regimen and staggered-release oral unit dosage forms (2021-02-02). Cantex Pharmaceuticals, Inc. [US]. Inventors: Stephen Marcus [US].

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4

Formulation and Quality Control of Curcumin-Boswellia Extract

Cited 1 time 2020

For the clinical study, the sunflower lecithin-based formulation of C. longa L. and B. serrata standardized extracts (500 mg) was prepared by Indena S.p.A., as oblong-shaped, film-coated tablets, corresponding to a content of 17.0–23.0% w/w of curcumin and 7.0–11.0% w/w of boswellia extracts, respectively by high performance liquid chromatography (HPLC) assay. The active ingredient is a solid dispersion containing the standardized association of curcumin extract (≥90% as total curcuminoids assessed by HPLC assay) and boswellia extract (≥65.0% of total triterpenic acids assessed by HPLC assay). The remaining food-grade components of the phytosome tablets are calcium carbonate E170 (95DC M; Dr Paul Lohman^®), polyvinylpolypyrrolidone E1202 (Polyplasdone^™ XL; Ashland), sodium croscarmellose E468 (Solutab^® A-IP; Blanver Farmoquimica LTDA), silicon dioxide E551 (Syloid^® 244FP; Grace), talc E553b (Mondo Minerals B.V.), magnesium stearate E470b (Ligafood^®; Peter Greven Nederland C.V.), and hydroxypropyl methylcellulose E463-based film-coating (Opadry^® Clear; Colorcon). Before releasing, the film-coated tablets containing the food-grade lecithin formulation were tested for appearance, average mass, uniformity of mass, HPLC-content of curcumin and boswellia extracts, disintegration time, and microbiological quality.

Giacosa A., Riva A., Petrangolini G., Allegrini P., Fazia T., Bernardinelli L., Gasparri C., Faliva M.A., Peroni G., Perna S, & Rondanelli M. (2020). Symptomatic uncomplicated diverticular disease management: an innovative food-grade formulation of Curcuma longa and Boswellia serrata extracts. Drugs in Context, 9, 2020-9-2.

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5

Formulation and Production of Coated Tablets

2020

MSZ (Erregiere), microcrystalline cellulose (JRS Pharma), partially pregelatinized maize starch (Colorcon), povidone (BASF), magnesium stearate (Mosselman), lactose monohydrate (Meggle), croscarmellose sodium (FMC BioPolymer), colloidal silicon dioxide (Evonik), talc (Luzenac), calcium carbonate (Shangai Nuoceng Pharmaceuticals). All the components were of pharmaceutical grade and complied with the relevant monographs of the European Pharmacopoeia, 9th edition [10]. Coating system: Opadry clear (Colorcon), Triethylcitrate (Colorcon), Acryl-Eze (Colorcon). Also purified water (Ph. Eur., 2016) was used in the process.
Process steps and equipment -laboratory batches weighing -balance (Mettler Toledo), wet granulation -fluid bed granulator (Bosch), manual blending, tableting -eccentric press (Riva).
Process steps and equipment -pilot batches weighing -balances and scales (Mettler Toledo), wet granulation -fluid bed granulator (Bosch), blendingblender (Servolift), tableting -rotary tableting press (Fette 102i), oblong punch 18.2/7.7 mm, coatingcoating equipment (O'Hara Technologies).

Chiş A.A., Crăciun I., Dobrea C.M., Gligor F.G., Bărbat A., & Rus L.L. (2020). Preformulation and preliminary formulation studies of mesalazine gastro-resistant tablets. Romanian Journal of Pharmaceutical Practice, 13(4), 207-213.

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Opadry clear

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Product FAQ

11 protocols using «opadry clear»

Curcuma longa and Boswellia serrata Phytosome

Bergamot and Artichoke Combination Supplement

Tailored Copper Gluconate Enteric Coatings

Formulation and Quality Control of Curcumin-Boswellia Extract

Formulation and Production of Coated Tablets

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