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Single-unit dosage form (SUDF) vs Multiple-unit dosage form (MUDF)

Advantages over simple (single-unit) tablets/capsules:

Reduces irritation of the gastric mucosa due to drug degradation of simple units

Improves dose adjustment

Offers the possibility to administer incompatible drugs due to the multiparticulate system

Multiple-Unit Pellet System (MUPS)

one of the most popular MUDF

multiparticulate drug delivery system

Features of controlled-release tablets + modified release capsules in one dosage form --> MUPS

Discrete delivery entities:

pellets

mini tablets

granules

beads

microspheres

3 dosage forms:

(compressed into) tablets - common

(filled into) capsules - common

(filled into) sachets

tablets of MUPS (TMUPS) preferred over capsules

Application

It has been shown that Omeprazole MUPS have increased bioavailability and improved pharmacological response

Recent Advanced of Multiple Unite Pellet System (MUPS) Technology in Formulation of Pharmaceutical Products: A Review | International Journal of Contemporary Research and Review (ijcrr.info)

Multiple-unit pellet system for modified drug release - 2012 - Wiley Analytical Science

https://www.sciencedirect.com/science/article/abs/pii/S0168365917307629?via%3Dihub

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The terms typically included in the ANOVA model for a bioequivalence study:

1. Sequence:

The sequence refers to the order in which subjects receive the test and reference treatments. For example, in this case which utilise crossover study design, subjects might receive either the test (tablet) or reference (capsule) treatment first, followed by the other treatment in a different sequence.

2. Subject within Sequence:

This term accounts for the variability between individual subjects within each sequence. Each subject may respond differently to the treatments due to factors like metabolism, age, or health status. Accounting for this variability helps to isolate the treatment effect from individual differences.

3. Period:

The period accounts for any temporal effects that may influence the response variable over the course of the study. This could include changes in environmental conditions, circadian rhythms, or other factors that could affect drug absorption, distribution, metabolism, or excretion.

4. Formulation:

The formulation term reflects the comparison between the test and reference formulations. This term assesses whether there are any differences in the response variable between the two formulations after accounting for other sources of variability.

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Effects of coating on the pharmacological action of the capsule (Karen)

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Effects of coating on the pharmacological action of the capsule (Karen)

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Enteric coating is a polymer (cellulose derivatives) applied to oral medication.

Designed to withstand the acidic environment of the stomach / (-) premature release

(dissolve in the more alkaline environment of the small intestine)

Serves as a barrier to prevent the gastric acids in the stomach from dissolving or degrading drugs.

Useful for drugs that are sensitive to gastric acid or that cause irritation to the stomach lining. By delaying release until the drug reaches the intestine, enteric coatings can also alter the site of absorption, potentially enhancing bioavailability or reducing side effects.

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Efficacy and Characteristics of Capsules vs Tablets

1. Which one acts faster?

Capsules tend to break down more quickly (act faster) than tablets --> offer faster relief from symptoms than Tablets.

2. Ease of Swallowing:

Opinion 1: The swallowing of capsules can be particularly difficult. This is because capsules are lighter than water and float due to air trapped inside the gelatin shell. In comparison, tablets are heavier than water and do not float.

Opinion 2:

Capsules: generally easier to swallow, especially for individuals who have difficulty swallowing solid dosage forms. The smooth, gelatinous shell of capsules allows for easier passage through the esophagus.

Tablets: larger and harder to swallow compared to capsules.

3. Which one can accommodate a higher dose?

Tablet can accommodate a higher dose of an active ingredient than a capsule.

4. Tablets can be split --> break in two for a smaller dose, but capsules can't be split (gelatin shell encloses the medication in either powder, granule, or pellet form).

5. Tablets are generally cheaper to manufacture than capsules --> more affordable for consumers.

6. Stability and Shelf Life:

Capsules:

Hard gelatin capsules are more prone to moisture absorption because gelatin is hygroscopic --> become brittle, soften & sticky.

Gelatin can degrade or become sticky at higher temperatures --> affect the stability.

sensitive to light and air

Due to the sensitivity to moisture and temperature --> shorter shelf life

Tablets:

Tablets are typically more stable than capsules --> providing longer shelf life and resistance to environmental factors (e.g. moisture and temperature)

composed of compressed powder, which is less prone to physical and chemical changes

have a coating that protects against moisture, light and air

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Yes, it is feasible as the generic drug demonstrates bioequivalence properties and meets regulatory requirements. Generic drugs typically cost less than their brand-name counterparts, which can result in significant cost savings for patients and company itself.

If the efficacy of generic tablet is higher than the innovator's capsule --> generic tablet may provide superior therapeutic outcomes or better patient response --> very good :) --> updating treatment practices to optimize patient outcomes.

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Based on Table 2, the 90% confidence interval (CI) for the ratio of the test and reference products (T/R ratio) falls within the acceptance interval of 80.00 - 125.00% (0.80 - 1.25), indicating the test formulation is bioequivalent to the reference formulation. (providing evidence of comparable pharmacokinetic performance)

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In an attempt to prevent the disintegration of enteric-coated HPMC capsules in HCl without sealing them, bodies and caps were coated separately to ensure coverage of the body with polymer, especially where the cap overlaps.

The method was reproducible and the thus coated capsules can be stored, either before filling or filled without affecting the enteric properties

The promising method for the production of enteric-coated HPMC capsules eliminates the need for the time-consuming and expensive sealing step and results in ready-to-use enteric-coated capsules that can be filled with heat and moisture-sensitive materials, without affecting their stability.

As no experience or equipment for coating is required, the ready-to-use enteric-coated capsules can be used in R&D departments as well as in retail or hospital pharmacy

Reference

https://sci-hub.se/https://doi.org/10.1016/j.ejps.2004.01.002

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Definition

Medication is created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as the brand-name medicine.

A generic drug may have certain minor differences from the brand-name product, such as different inactive ingredients.

Cost of Generic Drugs

Generic drugs tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. This abbreviated pathway is why the application is called an “abbreviated new drug application.”

Bioequivalence

The purpose of establishing bioequivalence is to demonstrate equivalence in biopharmaceutical quality between the generic medicinal product and a comparator medicinal product to allow the bridging of preclinical tests and clinical trials associated with the comparator medicinal product.

Reference

https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers

https://www.npra.gov.my/images/reg-info/BE/BE_Guideline_FinalMarch2015_endorsed_22PPWG.pdf

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Formulation of Generic Omeprazole Tablet (Elyra)

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Formulation of Generic Omeprazole Tablet (Elyra)

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Reference:

https://www.scirp.org/journal/paperinformation?paperid=58142

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Benefits of Tablets Over Capsule (Elyra)

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Benefits of Tablets Over Capsule (Elyra)

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Cost-effectiveness

Tablets are generally less expensive to produce than capsules, due to lower material costs and more efficient manufacturing processes.

This cost advantage can be especially significant for high-volume products or those with tight budget constraints.

A wider range of manufacturing options

Tablets can be psroduced using various techniques, such as direct compression, wet granulation, or dry granulation.

These different methods offer manufacturers flexibility in optimizing the tablet's properties, such as hardness, disintegration time, and drug release profile.

Stability & convenience

Tablets are typically more stable than capsules, providing longer shelf life and resistance to environmental factors like moisture and temperature.

Moreover, tablets can be scored, allowing patients to easily split them for precise dosing. This feature can be particularly beneficial for dose titration or when a product is used in different patient populations with varying dosage requirements.

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Tablet:

Content of active ingredient, uniformity of weight, uniformity of content, disintegration test (measures the ability to break down into smaller particles or granules), dissolution test (to study the release of a drug that affects the bioavailability), hardness test (range: 4-6kg), friability test (mimic forces caused by collisions and sliding to measure the resistance of

tablets or granules to abrasion

or fracture)

Friability loss = [(initial - final)/initial] x 100%

[max loss not more than 1%]

Capsules

Appearance, size, shape, identification marking, uniformity of weight, uniformity of content (API within range of 85-115% of the label claim), disintegration test, dissolution test, moisture permeation test (to assure the suitability of containers for packaging of capsules)

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How do we know whether the generic product is bioequivalent to the comparator?

90% Confidence Interval logAUC ratio & logCmax ratio falling between 80% and 125%

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In this case:

change from capsule to tablet, may affects the manufacturing process, revalidation is required

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In bioequivalence studies, a generic formulation must give similar drug plasma concentration as the reference drug (similar plasma concentration-time curve).

Figure 1 shows that the test formulation is bioequivalent to the reference formulation as they have similar/almost equivalent (but not exactly the same) Cmax and AUC.

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Potential benefits of Generic Omeprazole Tablet (MH)

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Potential benefits of Generic Omeprazole Tablet (MH)

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1. Stability: Tablets generally offer better stability compared to capsules, as they provide better protection against moisture and environmental factors. This can help maintain the integrity and potency of the active pharmaceutical ingredient (API) over time.

2. Manufacturing: Tablets are often easier and more cost-effective to manufacture in large quantities compared to capsules. They can be produced using high-speed compression methods, which may result in lower production costs.

3. Dosage Flexibility: Tablets allow for easier manipulation of dosage strength compared to capsules. Different dosages can be achieved through formulations such as scored tablets or controlled-release formulations, offering more options for patient treatment.

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mean ± SD - measure data variability

Difference between SD & MSE:

Mean Square Error (MSE) and Standard Deviation (SD) are both measures of dispersion

MSE quantifies the average squared difference between the observed values and the values predicted by a model.

SD measures the dispersion or variability of a set of data points around the mean. It indicates how much the individual data points deviate from the mean of the data set.

Analysis of variance (ANOVA) is a statistical test used to evaluate the difference between the means of more than two groups.

According to ASEAN guideline for the conduct of bioequivalence study, the statistical analysis (e.g. analysis of variance[anova]) should take into account sources of variation that can be reasonably assumed to have an effect on the response.

A smaller MSE indicates great test formulation's performance because it means that the values of PK parameters of test formulation are closer to the reference formulation.

Squaring the errors ensures that negative and positive deviations contribute equally to the overall measure.

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MSE for Cmax, AUCt and AUC of Test formulation (omeprazole tablet - Generic drug) and reference formulation (omeprazole capsule - Innovator drug) are small, indicate that the results of test formulation are close to reference formulation.

Null Hypothesis (H0): There is no significant difference in between the test formulation and reference formulation.

Alternative Hypothesis (H1): There is difference in between the test formulation and reference formulation.

If the p-value is less than the chosen significance level (in this case: 0.05), then reject the null hypothesis in favor of the alternative hypothesis. This suggests there is a statistically significant difference in between test and reference formulation.

Interpretation in terms of treatment: P value >0.05, null hypothesis is accepted. The formulation of the drug (test versus reference) did not significantly influence the outcome in terms of Cmax, AUCt and AUC being studied. In the context of a bioequivalence study, a non-significant formulation effect indicates that the test product is statistically equivalent to the reference product. This strengthens the evidence supporting the conclusion of bioequivalence between Omeprazole tablet (test) and capsule (reference).

Interpretation in terms of period: P value >0.05, null hypothesis is accepted. The period (time) at which the measurements (Cmax, AUCt and AUC) were taken did not significantly influence the outcome being studied.

Interpretation in terms of sequence: P value < 0.05, null hypothesis is rejected. There is significant Sequence Effect. The sequence in which subjects receive the treatments significantly influences the outcome being studied. This could imply carryover effects that need to be addressed or accounted for in the analysis. Carryover Effect:

The carryover effect occurs when the response to a treatment in one period influences the response to the subsequent treatment.

It can bias statistical results and affect the estimation of treatment differences.

Detecting and accounting for carryover effects are crucial to ensure valid conclusions.

Consideration for Study Design: A significant sequence effect may prompt researchers to reconsider the study design or explore potential reasons for the observed differences between sequences. Adjustments to the study protocol or statistical analysis may be necessary to account for these effects.

Interpretation in terms of subjects within sequence: P value < 0.05, null hypothesis is rejected. There is Significant Subject within Sequence Effect. Individual differences among subjects, such as variability in metabolism, absorption, or other physiological factors, have a significant impact on the response variable. This highlights the importance of accounting for subject variability in the analysis.

Consideration for Study Design: A significant subject within sequence effect may prompt researchers to further investigate factors contributing to individual variability, refine inclusion criteria for subjects, or consider alternative study designs to minimize the impact of individual differences.

In the context of bioequivalence study, subject within sequence effect may influence the interpretation of the study results and the conclusions drawn regarding the bioequivalence of the test and reference products.

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https://www.sciencedirect.com/science/article/abs/pii/S0168365917307629?via%3Dihub

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Significant Sequence and Subject within Sequence Effects

Non-Significant Formulation and Period Effects

Given these results, it raises questions about the bioequivalence of the test and reference formulations. The significant sequence and subject within sequence effects suggest that there may be confounding factors influencing the outcome that need to be addressed.

To improve the crossover design study and minimize potential biases in this scenario, several strategies could be considered:

1. Address Carryover Effects: Implementing appropriate washout periods between treatment periods can help minimize carryover effects, where the effects of one treatment persist into subsequent periods.

2. Increase Sample Size: A larger sample size can help improve the precision of estimates and increase the power of the study to detect differences if they exist.

3. Optimize Randomization: Ensure proper randomization of treatment sequences and subjects within sequences to minimize bias and improve the validity of the study results.

4. Consider Stratification: Stratify subjects based on relevant factors (e.g., age, gender, baseline characteristics) to control for potential sources of variability and improve the comparability of treatment groups.

5. Consult Regulatory Guidelines: Ensure that the study design and analysis plan align with regulatory guidelines and requirements for bioequivalence studies to facilitate acceptance of results by regulatory authorities.

By implementing these changes and addressing potential sources of bias, researchers can enhance the validity and reliability of crossover design studies and provide more robust evidence regarding the bioequivalence of test and reference formulations.

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https://analyticalscience.wiley.com/content/article-do/multiple-unit-pellet-system-modified-drug-release

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OMEPRAZOLE MUPS®: AN ADVANCED FORMULATION OFFERING FLEXIBILITY AND PREDICTABILITY FOR SELF MEDICATION - Selfcare Journal

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Process that damages the API in capsule/ Tablets (Shena)

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Process that damages the API in capsule/ Tablets (Shena)

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Errors in manufacturing processes (mixing, blending, granulation)

Improper packaging (inadequate sealing, light or moisture ingress)

Incorrect storage conditions (temperature, humidity)

Rough transportation (handling, extreme temperatures)

Lax quality control procedures (insufficient testing)

Chemical interactions during formulation with excipients

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https://iris.who.int/bitstream/handle/10665/62166/WHO_PHARM_93.562_rev.3.pdf?sequence=1&isAllowed=y

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Types of Capsule Coating & Excipient Used (Elyra)

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Types of Capsule Coating & Excipient Used (Elyra)

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1. Enteric Coating

Designed to resist the acidic environment of the stomach

Dissolve in the alkaline environment of the intestines, protecting the active ingredients from degradation

The coating can be formulated with the appropriate polymers (acrylic acid copolymer, HPMC AS or sodium alginate), coloring additives and additional excipients

Suitable for omeprazole

MOA: Suppress the final step of stomach acid secretion by specific inhibition of the proton pump in the lining of the stomach

Enteric-coated capsules have an acid-resistant coating that prevents them from dissolving when pass through the stomach

The capsules will not be activated until they pass through an alkaline environment (pH > 5.5)

Reduce stomach irritation

2. Aqueous Film Coating System

Soft gelatine capsules coated with BonuLac®,

based on natural shellac, an aqueous film coating system, with excellent moisture sealing and enteric properties.

3. Anti-Sticking Coating

Soft gelatine capsules coated with BonuWax®

4. TiO2 Free Coated Capsule

Organic, vegan, free of titanium dioxide, iron oxide and talcum etc

AquaPolish® natural colored has been applied.

The colors/pigments were made from fruits, vegetables & edible plants.

Free of titanium dioxide and iron oxides.

Reference:

https://www.biogrund.com/capsule-coating-2/?lang=en#:~:text=The%20coating%20prevents%20the%20capsule,without%20irritating%20the%20gastric%20mucosa.

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https://selfcarejournal.com/article/omeprazole-mups-an-advanced-formulation-offering-flexibility-and-predictability-for-self-medication/#:~:text=Omeprazole%2520MUPS%C2%AE%2520tablets%2520are,faster%2520in%2520the%2520fed%2520state.

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Both Tablet & Capsules has risk of dose dumping if they are formulated as a controlled released medication. Research found there is a slightly higher risk in Tablets > Capsules

Ways to overcome the Tablets Dose Dumping : MUPS Tablets

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The expected deviation from the comparator product ratio of T/R (delta between 5% to 10%)

If the T/R ratio falls between 0.95 and 1.05, it generally indicates bioequivalence.

(ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE STUDIES)

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Several polymers used for enteric coatings are:

Hydroxypropyl methylcellulose phthalate (HPMCP)

Diethyl Phthalate

Shellac

Polyvinyl acetate phthalate (PVAP)

CAP (cellulose acetate phthalate)

CAP offers a good balance between cost-effectiveness and established performance for enteric coatings. However, the final choice depends on the specific needs of the medication being coated.

If precise release control or other factors are crucial, a slightly more expensive option might be necessary.

eg Methacrylic Acid Copolymer (Kollicoat® MAE 30 DP)

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Which dosage form is more fragile? (Bryan)

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Which dosage form is more fragile? (Bryan)

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Tablets:

Tablets tend to be generally more fragile (Especially uncoated tablets).

Its fragility and brittleness depend on the compression force of the manufacturing process of the tablet.

Capsules:

The HPMC / Gelatin outer shell of capsules acts as a protective shell against impacts. (By absorbing the impact)

However, they are more susceptible to temperature and moisture changes compared to tablets.

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Why omeprazole (PPI) need enteric coated?  Weien

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Why omeprazole (PPI) need enteric coated?  Weien

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1. Sensitive to gastric acid. Omeprazole is easily protonated and therefore unstable at acid pH.

2. The acidic pH in the stomach prevents dissolution of the enteric coating. The more alkaline environment of the small intestine dissolves the coating to release the drug for absorption

3. Maintain the therapeutic efficacy of omeprazole by preventing degradation in the stomach

Sources:

1. Norman A, Hawkey CJ. What you need to know when you prescribe a proton pump inhibitor. Frontline Gastroenterology. 2011 Jun 24;2(4):199–205.

2. Howden CW. Clinical pharmacology of omeprazole. Clin Pharmacokinet 1991; 20: 38 49.

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Coating is needed for generic omeprazole tablet (Weien)

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Coating is needed for generic omeprazole tablet (Weien)

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Enteric coating can be applied to omeprazole tablets to protect the active ingredients from the acidic environment of the stomach.

Coating application:

Tablets: The enteric coating is usually sprayed or applied as a film over the compressed tablet.

Advantages:

prevent acid degradation

for optimal absorption

provide delayed release

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tablet hardness testing (crushing strength)

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tablet hardness testing (crushing strength)

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to determine the breaking point and structural integrity of a tablet and find out how it changes under conditions of storage, transportation, packaging and handling before usage.

The tablets should not be too hard or too soft, as a hard tablet could prevent the dissolution of the tablet, which is needed for an accurate dosage. However, if the tablet is too soft it could lead to quick disintegration, and it can easily chip or break during packaging and transport.

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Friability test - Friabilator/ friability tester

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Friability test - Friabilator/ friability tester

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Rotate the drum 100 times, with a speed of 25rpm, to test the durability of tablets during packing processes and transit.

It should be performed for compressed, uncoated tablet before the coating process.

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(to assure the suitability of containers for packaging of capsules)

Determined by packaging the dosage unit together with a color-revealing desiccant pellet, exposing the packaged unit to known relative humidity over a specified time, observing the desiccant pellet for color change (indicating the absorption of moisture), and comparing the pre-test and post-test weight of the packaged unit. The difference in the weights gives the amount of moisture absorbed.

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OMEPRAZOLE MUPS®: AN ADVANCED FORMULATION OFFERING FLEXIBILITY AND PREDICTABILITY FOR SELF MEDICATION - Selfcare Journal

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Appropriateness to Switch to Tablet (Elyra)

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Appropriateness to Switch to Tablet (Elyra)

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Not really for me :(

Based on Table 3, the p-value for the sequence and subject in the sequence is higher than 0.05, which raises a concern about the validity and reliability of the result. This indicates a difference in efficacy between the tablet and capsule if taken at different times and in different population groups.

However, there's sufficient evidence to believe that the efficacy of the tablet & capsule is the same as the p-value in the sense of treatment and period is less than 0.05, indicating no significant difference between the efficacy between tablet and capsule.

Hence, in this case, the company should conduct another bioequivalence study with a more comprehensive protocol (washout period, population selection, etc.) to further improve the safety profile of the generic tablet.

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Things to be Included Under this Section

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Things to be Included Under this Section

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If switching from an innovator's brand to a generic brand is feasible?

Reason for switching/not switching

What's next if the efficacy of generic tablet is higher than the innovator's capsule?

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Things to be Included Under this Section

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Things to be Included Under this Section

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Related NPRA guideline of bioequivalence

Criteria of bioequivalence

Acceptance interval

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Things to be Included Under this Section

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Which process will interfere/damage the API of the capsule/tablet?

Related guidelines of manufacturing protocol

The use of multiple unit pellet system (MUPS)

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Things to be Included Under this Section

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Things to be Included Under this Section

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Explain the efficacy of capsule and tablet in different aspects (eg: release profile)

Which dosage form is more fragile?

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Things to be Included Under this Section

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Things to be Included Under this Section

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List of QA testing for both capsule and tablets and BRIEFLY explain its function

Eg: Friability and dissolution testing

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Things to be Included Under this Section

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Things to be Included Under this Section

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Is revalidation needed in this case?

Related guideline

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Things to be Included Under this Section

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Should it have the same action as the capsule?

(In the sense of release profile)

The difference in dosing frequency

Risk of dose dumping

Discuss bioequivalence between the capsule and the new tablet

Similar PKPD profile?

Biowaiver possible?

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Things to be Included Under this Section

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BRIEFLY explain how generic omeprazole can be produced (side chain modification etc.)

Excipient used

Coating needed?

Benefits compared to the formulation of capsule

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Things to be Included Under this Section

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The decision to omit/not omit capsule coating

Effects of coating on the pharmacological action of capsule

Any other cheaper alternative that could achieve a similar effect instead of capsule coating?

What is the cost and material used?

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Things to be Included Under this Section

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Things to be Included Under this Section

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Types of capsule coating available other than enteric coating

Excipients/ingredients used for capsule coating

Suitable for omeprazole?