List of Excipients in Branded Drug PHYSICIANS CARE IBUPROFEN

Generic Drugs Containing PHYSICIANS CARE IBUPROFEN

Company	Ingredient	NDC	Excipient
Acme United Corporation	ibuprofen 200mg	0924-0075	CARNAUBA WAX
Acme United Corporation	ibuprofen 200mg	0924-0075	CELLULOSE, MICROCRYSTALLINE
Acme United Corporation	ibuprofen 200mg	0924-0075	FERRIC OXIDE RED
Acme United Corporation	ibuprofen 200mg	0924-0075	HYPROMELLOSES
Acme United Corporation	ibuprofen 200mg	0924-0075	LACTOSE
Acme United Corporation	ibuprofen 200mg	0924-0075	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in PHYSICIANS CARE IBUPROFEN?

# Of NDCs	Excipient
1	CARNAUBA WAX
1	CELLULOSE, MICROCRYSTALLINE
2	FERRIC OXIDE RED
1	HYPROMELLOSES
1	LACTOSE
1	MAGNESIUM STEARATE

Physicians Care Ibuprofen Excipient Strategy and Commercial Opportunities

Last updated: August 1, 2026

Physicians Care Ibuprofen is an over-the-counter ibuprofen product positioned for institutional, workplace, first-aid, hospitality, and emergency-kit distribution. Its commercial value is driven by low-cost tablet manufacturing, compliant packaging, channel access, and reliable supply rather than by prescription-drug exclusivity. The strongest excipient opportunities are formulation robustness, tablet disintegration, coating performance, allergen control, and differentiated dosage forms.

What is Physicians Care Ibuprofen?

Physicians Care Ibuprofen is an OTC immediate-release ibuprofen product, generally marketed as a 200 mg tablet for temporary relief of minor aches and pains and reduction of fever. The product is associated with the PhysiciansCare institutional first-aid and OTC supply channel.

Ibuprofen is a nonsteroidal anti-inflammatory drug regulated under the FDA OTC monograph framework for internal analgesic, antipyretic, and antirheumatic products. The applicable framework is codified principally in 21 C.F.R. Part 343, with labeling and active-ingredient requirements established by FDA regulation and the OTC monograph system.[1]

Product characteristic	Commercial assessment
Active ingredient	Ibuprofen
Typical OTC strength	200 mg
Dosage form	Immediate-release tablet
Therapeutic category	Analgesic, antipyretic, NSAID
Primary regulatory route	OTC monograph pathway
Likely customer base	Employers, schools, hospitality, industrial sites, clinics, first-aid distributors
Primary competitive factors	Unit cost, packaging, availability, tablet quality, private-label flexibility
Prescription-style exclusivity	Not applicable to the standard OTC monograph product
Biosimilar exposure	None; ibuprofen is a small-molecule drug
Main IP risk	Low for the standard active ingredient and conventional tablet

What excipients are used in Physicians Care Ibuprofen?

The precise formulation should be evaluated against the product’s current FDA labeling, package insert, and manufacturer documentation. Conventional immediate-release ibuprofen tablets typically use excipients from several functional classes:

Excipient function	Common materials in ibuprofen tablets	Strategic purpose
Diluent or filler	Microcrystalline cellulose, lactose, dibasic calcium phosphate, starch	Provides tablet mass and improves compressibility
Binder	Pregelatinized starch, povidone, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Croscarmellose sodium, crospovidone, sodium starch glycolate	Promotes tablet breakup after ingestion
Glidant	Colloidal silicon dioxide	Improves powder flow during compression
Lubricant	Magnesium stearate, stearic acid, sodium stearyl fumarate	Reduces sticking and ejection force
Coating system	Hypromellose, polyethylene glycol, titanium dioxide, colorants	Improves swallowability, appearance, and handling
Film former or polish	Hypromellose or similar polymer	Creates a uniform protective coating

Ibuprofen presents a formulation challenge because it has poor water solubility and can be difficult to process at high drug loading. The excipient system must balance powder flow, tablet hardness, disintegration, dissolution, and manufacturing speed. Excessive lubrication can slow dissolution. Excessive compression can produce tablets that pass mechanical testing but disintegrate slowly.

The most commercially relevant excipient strategy is therefore not simply the lowest-cost formula. It is a formulation that maintains rapid and consistent release while tolerating high-speed compression, long shelf life, and variable storage conditions.

How does ibuprofen’s active pharmaceutical ingredient affect excipient selection?

Ibuprofen is a weak acid with limited aqueous solubility. Particle size, crystal form, wetting, and tablet porosity can affect dissolution performance. These factors create several excipient-selection priorities.

Wetting and dissolution

Surfactants or wetting aids can improve contact between ibuprofen particles and gastrointestinal fluid. Their use must be balanced against taste, tablet stability, regulatory acceptability, and cost. A conventional immediate-release product may instead rely on particle engineering, disintegrants, compression control, and coating design.

Crospovidone and croscarmellose sodium are commercially attractive because they can promote rapid tablet breakup at relatively low concentrations. Sodium starch glycolate can also provide strong swelling, but its performance may be more sensitive to formulation and processing conditions.

Compression and sticking

Ibuprofen can create tableting problems, including sticking, picking, and poor powder flow. Colloidal silicon dioxide can improve flow, while magnesium stearate or sodium stearyl fumarate can reduce tooling friction. Lubricant concentration and mixing time require control because over-lubrication can reduce tablet tensile strength and delay disintegration.

Stability and moisture

A low-moisture excipient system can reduce stability risk where the API and formulation are sensitive to humidity. Packaging selection is closely connected to excipient strategy. Bottles with induction seals, desiccants, or higher moisture-barrier systems can support shelf life without changing the tablet formula.

Taste and swallowability

For adult 200 mg tablets, taste masking is usually less important than tablet size, coating smoothness, and ease of swallowing. Film coating can reduce chalkiness and improve product acceptance. A smaller tablet with higher drug loading may reduce packaging volume and shipping cost.

What formulation opportunities exist for Physicians Care Ibuprofen?

The strongest opportunities are line extensions and channel-specific formats rather than new chemical entities.

Immediate-release coated tablets

A conventional film-coated tablet is the lowest-risk platform. Optimization targets include:

• Faster and more consistent disintegration
• Reduced tablet weight
• Improved resistance to chipping and abrasion
• Lower coating weight
• Better performance in automated dispensing and first-aid packaging
• Reduced sensitivity to humidity

A direct-compression platform can reduce manufacturing steps. A wet-granulation platform may provide better content uniformity and flow, but it adds processing time and moisture exposure.

Caplets

Caplets can improve swallowability and provide a clear visual distinction from uncoated tablets. They may also support higher-speed packaging and better consumer recognition. The principal tradeoff is additional coating and tooling cost.

Chewable ibuprofen

A chewable dosage form could target children or consumers who have difficulty swallowing tablets. The excipient strategy would require sweeteners, flavors, taste-masking agents, and stronger control of palatability. This product would require careful pediatric labeling and age-appropriate dosing. The commercial opportunity is larger than for a standard institutional tablet, but the formulation and stability burden is also higher.

Liquid suspension

An ibuprofen oral suspension could serve pediatric, clinic, and first-aid channels. Key excipients would include suspending agents, wetting agents, buffers, preservatives where permitted, sweeteners, and flavor systems. The primary technical risks are sedimentation, redispersibility, viscosity, microbial control, and dose uniformity.

Single-dose packets

Single-dose pouches and blister packs are particularly relevant to PhysiciansCare’s institutional business. They can improve portability, dose control, tamper evidence, and inventory management. The main formulation issue is not the tablet itself but barrier protection, heat-seal compatibility, print durability, and resistance to crushing during distribution.

Fast-dissolving or orally disintegrating tablets

An orally disintegrating ibuprofen product could create differentiation, but it has a more difficult taste and loading profile than a standard 200 mg tablet. The format may be more suitable for lower strengths or pediatric use than for a full adult dose.

What is the FDA regulatory status of Physicians Care Ibuprofen?

Standard OTC ibuprofen products are generally regulated under the FDA OTC monograph system rather than through a product-specific new drug application. The applicable active ingredient, indication, dosing, warnings, and labeling must conform to FDA requirements.

The OTC monograph route reduces the importance of product-specific regulatory exclusivity. A competitor can enter with a compliant ibuprofen product without waiting for expiration of an innovator NDA patent estate, provided the product satisfies the applicable FDA conditions.

The manufacturer must control:

• Active ingredient identity and assay
• Content uniformity
• Tablet hardness and friability
• Disintegration and dissolution
• Stability and expiration dating
• Manufacturing controls
• Labeling and warnings
• Packaging and tamper-evident requirements
• Complaint, adverse-event, and recall systems

Ibuprofen products also carry NSAID-related warnings concerning gastrointestinal bleeding, cardiovascular events, allergic reactions, and use during pregnancy. Labeling compliance is a commercial requirement because institutional buyers often use standardized procurement specifications.

What is the Orange Book status of Physicians Care Ibuprofen?

Physicians Care Ibuprofen does not derive its market position from an Orange Book-listed patent estate in the manner of an NDA-based prescription product. OTC monograph products are generally not managed through the same patent-listing and Paragraph IV framework used for approved prescription NDAs.

The practical consequence is that a competing manufacturer normally does not need to file an Abbreviated New Drug Application with a Paragraph IV certification against Physicians Care Ibuprofen. A compliant OTC ibuprofen product can compete through the monograph or other applicable FDA pathway.

Orange Book issue	Assessment
Listed NDA exclusivity	Not the expected basis of protection
Listed formulation patents	No standard product-specific estate assumed
Paragraph IV risk	Generally not the principal entry mechanism
Generic substitution	Relevant mainly through retail and institutional purchasing
Competitive barrier	Manufacturing, quality, packaging, distribution, and customer contracts

When does Physicians Care Ibuprofen lose exclusivity?

Physicians Care Ibuprofen has no meaningful product-specific exclusivity period comparable to a patented prescription medicine. Ibuprofen itself has been available for decades, and the standard 200 mg OTC market is open to multiple manufacturers and private-label suppliers.

Commercial exclusivity may still arise from:

• Customer contracts
• Preferred supplier status
• First-aid kit specifications
• Distributor relationships
• Private-label arrangements
• Packaging designs
• Brand recognition
• Reliable fill rates
• Institutional procurement approvals

These protections are commercial rather than pharmaceutical exclusivities. They can be lost when a competitor offers a lower delivered cost, better packaging, stronger service levels, or a more attractive contract structure.

What patents protect Physicians Care Ibuprofen?

The standard ibuprofen molecule, conventional 200 mg immediate-release tablet, and basic OTC use are not expected to provide meaningful current patent protection. Potential patentable subject matter would instead arise from a specific technical implementation, such as:

• A novel controlled-release profile
• A specialized particle-size distribution
• A solid dispersion or amorphous formulation
• A taste-masked pediatric composition
• A novel oral suspension system
• A unique blister or unit-dose package
• A manufacturing process with measurable advantages
• A combination product
• A specialized method of reducing gastrointestinal exposure or improving tolerability

Any patent analysis must distinguish between patents assigned to a product manufacturer and patents that actually cover the marketed Physicians Care formulation. A broad search for the term "ibuprofen" will produce many historical patents that do not block a conventional OTC tablet.

How strong is the patent estate for Physicians Care Ibuprofen?

The patent estate is weak for the standard product category and potentially stronger only for a differentiated formulation or delivery system.

IP category	Expected strength for standard Physicians Care Ibuprofen
Ibuprofen composition of matter	Minimal
Conventional immediate-release tablet	Minimal
Standard OTC analgesic indication	Minimal
Film coating	Low unless technically distinctive
Unit-dose packaging	Low to moderate, depending on claims
Pediatric suspension	Moderate if formulation-specific
Taste-masked dosage form	Moderate if supported by technical data
Controlled release	Moderate to high if clinically and technically differentiated
Manufacturing process	Moderate if difficult to design around
Brand and trade dress	Commercially relevant but separate from patent rights

A formulation patent is strongest when it claims measurable performance, includes a narrow but commercially important composition range, and has data showing improved dissolution, stability, tolerability, or manufacturability.

What generic entry risks exist for Physicians Care Ibuprofen?

Generic and private-label entry risk is high for the conventional product. The API is widely available, the dosage form is familiar, and manufacturing technology is mature.

The most likely competitive entrants are:

1. Large OTC manufacturers with existing ibuprofen capacity.
2. Private-label suppliers serving pharmacies and mass merchants.
3. Contract manufacturers selling institutional products.
4. First-aid kit companies sourcing ibuprofen from multiple suppliers.
5. International manufacturers competing through import or distributor channels.

Entry barriers remain in quality systems, FDA compliance, supply continuity, packaging qualification, and institutional contracting. These barriers can delay commercial entry but generally do not create durable exclusivity.

Which commercial opportunities are most attractive?

Institutional unit-dose packaging

Single-dose pouches and blister cards are the clearest opportunity for PhysiciansCare. Employers, schools, hotels, transportation companies, and industrial facilities value portability, inventory control, and clear dosing instructions.

The product can be sold as part of a broader first-aid procurement program rather than as a standalone tablet. This increases account value and reduces direct comparison with retail shelf pricing.

Private-label and co-branded supply

A flexible excipient and packaging platform can support multiple customers without changing the active ingredient. Variations can include tablet color, imprint, pouch artwork, carton configuration, and kit count.

The principal commercial requirement is manufacturing flexibility. A supplier that can produce short and medium runs with validated packaging changes may compete effectively against larger high-volume manufacturers.

Low-allergen positioning

A product can target procurement specifications that exclude selected excipients, including lactose, artificial colorants, gluten-containing materials, or animal-derived ingredients. Each claim requires substantiation and careful control of supplier declarations.

This opportunity is more credible when the product has a transparent inactive-ingredient profile and a documented change-control process.

Sustainable packaging

Reduced-material blister systems, recyclable cartons, and lower-plastic unit-dose formats may improve institutional procurement scores. Packaging changes must preserve child resistance where required, tamper evidence, moisture protection, and product integrity.

Pediatric and liquid extensions

Pediatric ibuprofen can expand the addressable market, but it requires stronger control of flavor, dosing devices, labeling, and age-related safety. A suspension or chewable product would have greater differentiation than another adult tablet but would also create higher development and quality costs.

How does Physicians Care Ibuprofen compare with competing OTC products?

Attribute	Physicians Care Ibuprofen	Retail branded ibuprofen	Store-brand ibuprofen	Pediatric ibuprofen
Primary channel	Institutional and first-aid	Retail pharmacy and e-commerce	Retail and wholesale	Retail, pediatric, clinic
Typical dosage form	Tablet or unit dose	Tablet, caplet, softgel	Tablet, caplet, softgel	Suspension or chewable
Main buyer	Organization or distributor	Consumer	Retailer or consumer	Parent or caregiver
Price sensitivity	High delivered-cost sensitivity	Brand and promotion sensitive	Very high	Moderate
Differentiation	Packaging, availability, service	Brand, dosage forms, promotion	Price	Taste, dosing, convenience
Patent strength	Low for standard tablet	Low to moderate for specialized formats	Low	Higher only for specialized delivery

Softgels and liquid-filled capsules may offer faster perceived onset or easier swallowing, but they typically involve higher manufacturing and packaging costs. PhysiciansCare can compete more effectively where customers prioritize unit-dose convenience and procurement simplicity over premium dosage forms.

What litigation and settlement risks affect Physicians Care Ibuprofen?

No product-specific Paragraph IV litigation or settlement structure is expected to define the standard OTC Physicians Care Ibuprofen market. The more relevant legal risks are:

• Product liability claims
• Failure-to-warn allegations
• Manufacturing deviations
• Labeling noncompliance
• Packaging defects
• Trademark disputes
• Contract disputes with distributors
• Recalls involving contamination, mix-ups, or stability failures

For a new formulation, litigation exposure could increase if the product enters a patented softgel, controlled-release, pediatric, or combination-product segment. Freedom-to-operate analysis should focus on active formulation claims, release profiles, manufacturing processes, and packaging claims rather than on the expired or widely available ibuprofen active ingredient.

What manufacturing and IP barriers matter most?

The main barriers are operational:

• Consistent API particle-size control
• Low-defect high-speed compression
• Robust lubrication control
• Reliable dissolution after aging
• Coating uniformity
• Moisture-barrier packaging
• Validated unit-dose sealing
• Supplier qualification for excipients
• Traceability across contract manufacturers
• Rapid response to shortages and recalls

A defensible commercial position can be built around a validated platform that produces consistent tablets at low cost across multiple package formats. The most valuable know-how may be confidential manufacturing knowledge rather than patent claims.

Key Takeaways

• Physicians Care Ibuprofen is primarily an OTC institutional and first-aid product.
• Its standard 200 mg immediate-release tablet has limited patent-based protection.
• Generic and private-label entry risk is high because ibuprofen and conventional tablet technology are mature.
• Excipients should be selected for dissolution, compressibility, low defect rates, stability, and packaging compatibility.
• Crospovidone, croscarmellose sodium, microcrystalline cellulose, starch-based binders, colloidal silicon dioxide, and controlled lubrication are common formulation tools.
• Single-dose pouches, blister packs, and first-aid kit integration offer the strongest commercial opportunities.
• Pediatric suspensions, chewables, taste-masked products, and specialized release systems provide greater differentiation but carry higher development risk.
• The key competitive assets are procurement relationships, supply reliability, packaging flexibility, and quality performance.
• FDA OTC compliance, labeling, manufacturing controls, and product-liability management are more important than Paragraph IV litigation for the standard product.

FAQs

Is Physicians Care Ibuprofen a generic drug?

It is an OTC ibuprofen product competing in a market populated by branded, store-brand, private-label, and institutional products. Its market position does not depend on prescription-drug exclusivity.

Can a company patent a new ibuprofen tablet formulation?

Yes. A company may seek patents for a technically novel formulation, release profile, manufacturing process, taste-masking system, suspension, or packaging configuration. A conventional ibuprofen tablet is unlikely to support strong new patent protection without a distinctive technical feature.

Which excipient is best for faster ibuprofen tablet dissolution?

No single excipient determines dissolution. Disintegrant selection, API particle size, wetting, tablet porosity, compression force, lubricant level, and coating design act together. Crospovidone and croscarmellose sodium are common starting points for immediate-release development.

Does Physicians Care Ibuprofen have biosimilar competition?

No. Ibuprofen is a chemically synthesized small molecule, not a biologic. Competition comes from generic, private-label, and branded OTC products rather than biosimilars.

What is the best commercial extension for Physicians Care Ibuprofen?

For the existing institutional channel, unit-dose packaging integrated into first-aid kits is the lowest-risk extension. For broader consumer differentiation, pediatric suspension, chewable, or taste-masked formats offer more opportunity but require greater formulation, labeling, and quality investment.

References

1. U.S. Food and Drug Administration. (2024). OTC monograph M013: Internal analgesic, antipyretic, and antirheumatic drug products. https://www.fda.gov
2. Electronic Code of Federal Regulations. (2024). 21 C.F.R. Part 343: Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. https://www.ecfr.gov
3. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
4. National Library of Medicine. (2024). DailyMed: Ibuprofen drug labeling. https://dailymed.nlm.nih.gov/dailymed/
5. U.S. Food and Drug Administration. (2024). Drug safety communication: Non-steroidal anti-inflammatory drugs. https://www.fda.gov/drugsafety