List of Excipients in Branded Drug POTASSIUM CHLORIDE EXTENDED RELEASE

Generic Drugs Containing POTASSIUM CHLORIDE EXTENDED RELEASE

Company	Ingredient	NDC	Excipient
Padagis US LLC	potassium chloride	0574-0274	ALUMINUM OXIDE
Padagis US LLC	potassium chloride	0574-0274	FD&C BLUE NO. 1
Padagis US LLC	potassium chloride	0574-0274	FD&C BLUE NO. 2
Padagis US LLC	potassium chloride	0574-0274	HYDROGENATED COTTONSEED OIL
Padagis US LLC	potassium chloride	0574-0274	MAGNESIUM STEARATE
Padagis US LLC	potassium chloride	0574-0274	POLYETHYLENE GLYCOL
Padagis US LLC	potassium chloride	0574-0274	POLYVINYL ALCOHOL

What are the Most Frequently-Used Excipients in POTASSIUM CHLORIDE EXTENDED RELEASE?

# Of NDCs	Excipient
6	ALUMINUM OXIDE
3	CELLULOSE, MICROCRYSTALLINE
5	D&C YELLOW NO. 10
1	D&C YELLOW NO. 10 ALUMINUM LAKE
1	ETHYLCELLULOSE
5	FD&C BLUE NO. 1
5	FD&C BLUE NO. 2

Potassium Chloride Extended-Release Excipient Strategy and Commercial Opportunities

Last updated: August 5, 2026

Potassium chloride extended-release products are mature oral solid-dose medicines with limited active-ingredient differentiation. Commercial value is concentrated in release-control technology, gastrointestinal tolerability, dose flexibility, swallowability, manufacturing reliability, and supply performance. The strongest opportunities are generic substitution, private-label supply, sprinkle or liquid-adjacent formats, lower-irritancy formulations, and hospital or specialty-pharmacy packaging.

What products contain potassium chloride extended release?

Potassium chloride extended release is marketed primarily as tablets, microencapsulated capsules, and oral liquid or powder alternatives. The main commercial products include:

Product type	Representative product	Typical strength	Release technology	Primary commercial issue
Extended-release tablet	Klor-Con M	10 mEq, 20 mEq	Matrix or coated solid dosage system	Swallowability and gastrointestinal tolerability
Extended-release tablet	Generic potassium chloride ER	10 mEq, 20 mEq	Formulation-specific controlled release	ANDA substitutability and manufacturing cost
Microencapsulated capsule	Micro-K	8 mEq, 10 mEq	Microencapsulated potassium chloride crystals	Capsule size, sprinkling, dose flexibility
Oral solution or powder	Potassium chloride oral solution or powder products	Variable	Immediate-release liquid or dissolved salt	Taste, dosing accuracy, and potassium-load management

Potassium chloride is used to prevent or treat hypokalemia. Extended-release products are generally intended to reduce rapid potassium exposure and improve dosing convenience, but they remain high-potential-irritancy products. Product labeling commonly warns against crushing, chewing, or dissolving extended-release tablets because those actions can alter release and increase gastrointestinal exposure [1-4].

What excipients are used in potassium chloride extended-release products?

The core excipient strategy combines a release-controlling polymer or coating with tableting aids, lubricants, glidants, and stability-supporting ingredients.

Common excipient classes

Excipient class	Typical examples	Functional purpose
Release-control polymer	Ethylcellulose, hypromellose	Controls water penetration and potassium diffusion
Matrix former	Microcrystalline cellulose, hypromellose	Provides tablet structure and modifies release
Binder	Hypromellose, povidone, cellulose derivatives	Improves granule and tablet strength
Lubricant	Magnesium stearate, stearic acid	Reduces tooling adhesion and ejection force
Glidant or anti-caking agent	Colloidal silicon dioxide, talc	Improves powder flow and blend uniformity
Capsule shell	Gelatin or hypromellose	Encapsulates microgranules or microcrystals
Colorant	Iron oxides, FD&C dyes, titanium dioxide where permitted	Product identification and differentiation
Osmotic or solubility modifier	Salts, sugars, polymers	Adjusts water ingress and dissolution behavior

Product-specific inactive ingredients must be taken from the applicable FDA labeling record. Klor-Con M labeling identifies excipients including ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, and talc, although the exact composition can vary by strength and product version [1]. Micro-K uses a capsule-based, microencapsulated approach and has a different excipient and manufacturing profile [2].

How does the excipient strategy control potassium release?

Potassium chloride is highly water soluble. A conventional immediate-release tablet can dissolve rapidly and expose the gastrointestinal tract to a concentrated potassium load. Extended-release products therefore need a barrier that slows liquid penetration, potassium dissolution, or drug diffusion.

Polymer-matrix approach

A hydrophilic polymer such as hypromellose hydrates after contact with gastrointestinal fluid. The resulting gel layer slows potassium migration. Release depends on polymer viscosity, concentration, particle size, tablet porosity, compression force, and tablet dimensions.

This approach has relatively simple manufacturing and can support high-throughput direct compression or wet granulation. Its principal development risks are batch-to-batch dissolution variability and sensitivity to tablet hardness.

Coated-particle or microencapsulation approach

Ethylcellulose or another water-insoluble film former can coat potassium chloride particles or granules. Pore formers and coating weight determine the release rate. Microencapsulation can improve dose distribution and support capsule filling or sprinkle-oriented products.

The process is more complex than a simple matrix tablet. Critical variables include coating uniformity, residual solvent where applicable, particle-size distribution, agglomeration, coating defects, and capsule-fill weight variation.

Multilayer or combination approaches

A multilayer tablet can combine immediate-release and extended-release fractions. This may support faster symptom-directed replacement while maintaining prolonged exposure. It also increases tooling, process validation, dissolution, and scale-up requirements.

What excipients improve gastrointestinal tolerability?

Excipients cannot eliminate the intrinsic gastrointestinal risks associated with potassium chloride. They can reduce local concentration and manage release kinetics.

The most commercially relevant formulation objectives are:

1. Distribute potassium across a larger tablet or capsule volume.
2. Prevent rapid dissolution at one gastrointestinal location.
3. Maintain release after exposure to acidic and neutral media.
4. Avoid release acceleration caused by tablet fracture or dose manipulation.
5. Preserve mechanical integrity during packaging, shipping, and dispensing.

A formulation with slower dissolution is not automatically superior. Excessive release retardation can reduce clinical utility, create food-effect concerns, or produce unacceptable variability in patients with altered gastrointestinal transit.

What formulation patents protect potassium chloride extended release?

The original formulation concepts for potassium chloride extended release include wax matrices, polymer-coated particles, microencapsulation, multilayer tablets, and controlled-release oral dosage forms. Most foundational patent claims for these technologies are old and are likely expired or commercially irrelevant in the United States.

Current competitive protection is more likely to arise from:

• Product-specific formulation patents;
• Manufacturing-process patents;
• Coating-process controls;
• Sprinkle or dispersible dosage-form claims;
• Abuse-deterrent or tamper-resistant designs;
• Combination products;
• Device or packaging claims;
• Trade secrets covering granulation, coating, and dissolution control.

The FDA Orange Book should be checked by product and application number for current patent listings and regulatory exclusivity [5]. A generic applicant must analyze both listed patents and non-listed patent risks. Because potassium chloride extended release is a small-molecule generic product, biosimilar exclusivity does not apply.

What is the Orange Book status of potassium chloride extended release?

Potassium chloride extended-release tablets and capsules are regulated through abbreviated new drug applications, or ANDAs, when a generic applicant demonstrates pharmaceutical equivalence and bioequivalence to a reference-listed drug.

The commercial regulatory framework is:

Issue	Relevance
Reference-listed drug	Determines the ANDA reference product and dosage-form comparison
Therapeutic-equivalence rating	An AB rating can support pharmacy substitution under state law
Orange Book patents	May delay or complicate approval if unexpired and listed
180-day exclusivity	May apply to a first qualified Paragraph IV ANDA
New-drug exclusivity	Usually limited for this mature product class
Labeling	Must generally conform to the reference product
Dissolution	Central to release-control equivalence
Manufacturing site	Important because coating and content uniformity affect product performance

Orange Book status can change as applications are approved, withdrawn, or updated. A commercial launch analysis should use the current FDA Orange Book entry rather than relying on historical patent summaries [5].

When does potassium chloride extended release lose exclusivity?

The active ingredient has long been off patent. The relevant exclusivity question is therefore product-specific, not molecule-specific.

For mature potassium chloride extended-release products, generic competition is generally possible through ANDA approval unless a current listed patent, regulatory exclusivity period, settlement restriction, manufacturing problem, or supply constraint blocks entry. In practical terms, most commercial barriers are formulation execution and market access rather than basic compound patent protection.

A generic launch timeline usually includes:

Stage	Typical commercial significance
Reference-product selection	Defines the target dosage form and strength
Formulation development	Establishes release profile and manufacturability
Bioequivalence and dissolution package	Supports ANDA submission
Paragraph IV certification, if applicable	Creates litigation risk and possible 30-month stay
FDA review	Determines approval and labeling status
Technology transfer and validation	Establishes commercial-scale reproducibility
Launch	Depends on approval, litigation, supply, and customer contracts

Which companies are challenging potassium chloride extended release?

Competition is fragmented across branded manufacturers, generic companies, contract manufacturers, and private-label distributors. Representative commercial participants have included Upsher-Smith for Klor-Con products and manufacturers supplying generic potassium chloride ER tablets or capsules.

The principal competitive groups are:

• Branded or legacy product owners;
• Large generic manufacturers;
• Regional generic companies;
• Contract development and manufacturing organizations;
• Hospital and institutional suppliers;
• Private-label pharmacy distributors.

The market does not require a new active ingredient. A company can compete by securing an approved ANDA, acquiring an approved product, licensing a formulation, or supplying an existing product under a private-label arrangement.

What generic entry risks exist for potassium chloride extended release?

Generic entry risk is high at the active-ingredient level but varies by dosage form.

Tablet risks

Tablet products face relatively low intellectual-property barriers. The principal risks are:

• Failure to match dissolution across multiple media;
• Dose dumping after mechanical damage;
• Poor content uniformity caused by potassium chloride density;
• Capping, sticking, or lamination during compression;
• Excessive tablet size;
• Difficulty maintaining release after scale-up;
• Failure to achieve consistent coating or matrix hydration.

Capsule risks

Microencapsulated capsules may have more defensible process know-how. Risks include:

• Nonuniform coating thickness;
• Crystal fracture during handling;
• Capsule-fill variability;
• Powder segregation;
• Shell brittleness;
• Patient difficulty swallowing;
• Limited ability to use standard capsule-filling equipment.

Liquid and powder risks

Liquid and powder products create a different risk profile. Their challenges include taste masking, concentrated potassium dosing, measurement accuracy, package compatibility, and accidental dosing errors. These products may offer commercial differentiation but require stronger human-factors and labeling controls.

What commercial opportunities exist for potassium chloride extended release?

Lower-cost generic supply

The largest opportunity is reliable, low-cost supply of 10 mEq and 20 mEq tablets. Hospitals, retail pharmacies, wholesalers, and long-term-care providers value consistent availability because potassium replacement is routine and clinically important.

A manufacturer with efficient direct compression, robust process controls, and multiple packaging configurations can compete even without patent differentiation.

Improved swallowability

Potassium chloride tablets can be large relative to the dose delivered. Opportunities include:

• Smaller high-density tablets;
• Bilayer tablets;
• Capsule-based microgranules;
• Easier-to-swallow shapes;
• Lower tablet count through higher-strength presentations where clinically appropriate.

Any size reduction must preserve dissolution, content uniformity, and dose reliability.

Sprinkle and administration flexibility

Microencapsulated products may support administration by sprinkling contents on soft food, subject to product labeling. A properly engineered sprinkle product could target patients with dysphagia, older adults, and long-term-care populations.

The formulation must prevent premature rupture of the coated particles during handling and consumption. Labeling must clearly define permitted administration methods.

Pediatric and geriatric positioning

Pediatric use requires particular attention to dosing precision, taste, particle size, and administration volume. Geriatric use emphasizes swallowability, pill burden, renal-function monitoring, and medication adherence.

A pediatric or geriatric formulation may require a new drug application, supplemental application, or ANDA strategy depending on the reference product and proposed labeling.

Hospital and institutional packaging

Unit-dose blister packs, barcoded packaging, tamper-evident cartons, and automated-dispensing compatibility can create value without changing the active ingredient. Institutional customers may prioritize:

• Low dispensing error rates;
• Stable shelf life;
• Unit-dose availability;
• Packaging that withstands automated pharmacy systems;
• Predictable replenishment;
• National distribution coverage.

Supply-resilience positioning

Potassium chloride products are inexpensive, so manufacturing interruptions can have disproportionate operational effects. Dual-source API procurement, redundant coating capacity, regional packaging, and inventory planning can support institutional contracts.

The strongest opportunity is often supply reliability rather than premium pricing.

How strong is the patent estate for potassium chloride extended release?

The patent estate is generally weak for the basic compound and mature dosage-form concepts. It can be stronger for a specific commercial formulation if the sponsor has a later-filed patent covering:

• A defined polymer ratio;
• A narrow dissolution profile;
• A microencapsulated particle architecture;
• A specific manufacturing sequence;
• A novel sprinkle or dispersible product;
• A combination with another electrolyte;
• A device, package, or administration system.

Patent strength should be assessed claim by claim. Broad claims covering potassium chloride in a generic extended-release matrix are vulnerable because of extensive prior art. Narrow process and performance claims may be more defensible but are harder to enforce if the manufacturing route is not publicly observable.

What patent litigation and Paragraph IV issues affect the market?

Paragraph IV risk is product-specific. An ANDA applicant certifying that a listed patent is invalid or not infringed may trigger litigation within 45 days of notice. Litigation can produce a 30-month stay of approval under the Hatch-Waxman framework, subject to statutory exceptions and court action [6].

For potassium chloride extended-release products, litigation exposure is more likely to involve formulation or process patents than active-ingredient patents. Settlement agreements could delay launch, authorize an earlier entry date, or impose supply or licensing terms. Such agreements should be reviewed through FDA settlement reporting and court dockets.

No biosimilar litigation framework applies because potassium chloride is a synthetic small molecule, not a biologic.

How does potassium chloride extended release compare with competing electrolyte products?

Product	Main advantage	Main limitation	Excipient opportunity
Potassium chloride ER tablet	Low cost and established dosing	Large tablets and gastrointestinal concerns	Better matrix control and smaller dosage form
Potassium chloride microencapsulated capsule	Flexible particle-based release	More complex manufacturing and capsule handling	Improved sprinkle performance
Potassium chloride oral solution	Dose flexibility and no tablet swallowing	Taste and measurement burden	Taste masking and calibrated packaging
Potassium citrate ER	Alternative potassium salt with urinary alkalinization	Different clinical indication and electrolyte profile	Controlled dissolution and lower pill burden
Potassium bicarbonate products	Potassium delivery with bicarbonate	Different acid-base and formulation considerations	Effervescent or dissolving formats

Potassium citrate and potassium bicarbonate are not direct therapeutic substitutes in every clinical setting. The choice depends on the indication, acid-base requirements, renal status, and prescriber preference.

What FDA regulatory strategy supports a new potassium chloride ER product?

An ANDA is usually the most efficient pathway for a product that matches an approved reference-listed drug in active ingredient, strength, dosage form, route, and labeling. The development program should prioritize:

1. Reference-product characterization;
2. Comparative dissolution in discriminatory media;
3. Release behavior after crushing or mechanical stress;
4. Tablet hardness and friability controls;
5. Potassium assay and content uniformity;
6. Stability under moisture and temperature stress;
7. Packaging compatibility;
8. Bioequivalence strategy;
9. Labeling conformity;
10. Commercial-scale process validation.

A materially different dosage form, administration method, strength, or clinical use may require a different regulatory pathway. FDA product-specific guidance, where available, should be reviewed before finalizing the formulation and bioequivalence plan [7].

Key Takeaways

• Potassium chloride extended release is a mature, highly genericized small-molecule market.
• The main formulation technologies are polymer matrices, coated particles, microencapsulation, and multilayer tablets.
• Ethylcellulose, hypromellose, microcrystalline cellulose, magnesium stearate, talc, gelatin, and capsule-shell materials are common excipient categories.
• The main commercial differentiators are dissolution consistency, gastrointestinal tolerability, swallowability, sprinkle capability, packaging, and supply reliability.
• Basic compound patent protection is not the principal barrier. Product-specific formulation, process, packaging, and regulatory issues matter more.
• ANDA approval and therapeutic equivalence are central to generic competition.
• Paragraph IV risk is possible but must be assessed against the current Orange Book record for each reference product.
• Biosimilar risk does not apply.
• The most credible commercial opportunities are low-cost reliable supply, improved dosage-form usability, institutional packaging, and microencapsulated or flexible-administration products.

FAQs

Can potassium chloride extended-release tablets be crushed?

Generally no. Crushing or chewing can disrupt the release mechanism and increase gastrointestinal exposure. Product-specific labeling controls the permitted administration method [1,3].

Which excipient is most important for potassium chloride extended-release performance?

The release-controlling polymer or coating system is usually the most important. Ethylcellulose and hypromellose can materially affect water penetration, diffusion, and dissolution.

Is potassium chloride extended release suitable for a 505(b)(2) strategy?

A 505(b)(2) strategy may be relevant for a materially different formulation, administration method, or clinical use, but a conventional equivalent generic product is ordinarily evaluated through an ANDA pathway.

Can a potassium chloride capsule be opened and sprinkled on food?

Only if the applicable product labeling permits that method. Microencapsulated products may support sprinkling, but opening a conventional extended-release capsule or altering its contents can change dose delivery.

What is the strongest commercial moat in this market?

The strongest practical moat is usually manufacturing reliability combined with an approved product, stable supply, broad distribution, and a formulation that performs consistently across dissolution, stability, and scale-up conditions.

References

1. DailyMed. (n.d.). Klor-Con M potassium chloride extended-release tablets prescribing information. U.S. National Library of Medicine.

2. DailyMed. (n.d.). Micro-K potassium chloride extended-release capsules prescribing information. U.S. National Library of Medicine.

3. DailyMed. (n.d.). Potassium chloride extended-release tablets prescribing information. U.S. National Library of Medicine.

4. U.S. Food and Drug Administration. (2023). Potassium chloride prescribing information and product labeling resources. FDA.

5. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. FDA.

6. U.S. Code. (2023). 21 U.S.C. § 355(j): Abbreviated applications for new drugs.

7. U.S. Food and Drug Administration. (n.d.). Product-specific guidances for generic drug development. FDA.