We specialize in topical, transdermal, nasal, ophthalmic, and other complex drug delivery routes, offering a tailored approach to ensure the best formulation strategy for your product.

Why Choose MedPharm?

✔ Unrivaled Topical & Transdermal Expertise – Over 25 years of industry-leading formulation development.
✔ Proprietary Technologies – Innovations such as MedSpray® enhance product performance.
✔ Regulatory & Clinical Insight – Proven track record of 85+ approved products globally.
✔ Flexible, Collaborative Partnership – Customized strategies tailored to your development goals.

Evaluation & Planning Services

Strategic Foundations for Formulation Success

At MedPharm, effective formulation starts with thoughtful planning. Our Evaluation & Planning Services provide the foundation for product success by integrating scientific rigor, strategic foresight, and regulatory insight. Before any batch is mixed, we ensure your therapeutic goals align with technical feasibility, patient usability, and global compliance standards.

Whether you are developing a new molecular entity or reformulating an existing product, MedPharm ensures that each formulation is designed for efficacy, stability, manufacturability, and patient compliance.

🔍 Core Areas of Expertise:

• Target Product Profile (TPP) Development

• • We collaborate with your team to define the ideal attributes for your product, including dosage form, application site, release kinetics, and shelf life. The TPP serves as a blueprint that guides your formulation strategy, regulatory planning, and clinical success.

• API Characterization

Understanding the physicochemical and biological properties of your Active Pharmaceutical Ingredient (API) is essential. We assess solubility, polymorphism, pKa, stability, and hygroscopicity to identify formulation constraints and inform excipient selection and delivery strategies.

• In Silico Prediction & In Vitro Assessment

We utilize predictive modeling and early-stage in vitro testing to forecast API behavior across different delivery routes and dosage forms. These tools help identify optimal candidates and reduce risks in early development decisions.

✅ Benefits of Our Evaluation & Planning Services:

• Faster, Smarter Formulation Decisions

Accelerate development cycles by aligning formulation goals with API capabilities from the outset.

• Risk Mitigation

Identify and address challenges related to stability, solubility, and compatibility before they hinder your timeline.

• Regulatory Alignment

Ensure that early-phase data generation supports your IND, NDA, or ANDA strategies.

• Cross-Functional Integration

Connect your formulation plans with clinical, analytical, and manufacturing objectives from day one.

🔗 Explore Related Services:

[Pre-Formulation Services →]

[Formulation & Optimization →]

[Process Development →]

API Characterization

Understanding Drug Properties for Optimal Formulation and Stability

At MedPharm, our API Characterization services provide critical insights into the physical, chemical, and stability properties of an active pharmaceutical ingredient (API). By conducting comprehensive analytical assessments, we help pharmaceutical companies optimize drug formulation, improve bioavailability, and mitigate stability risks before advancing to clinical development.

A thorough understanding of API properties facilitates precise formulation design, the selection of excipients, and regulatory compliance, ensuring that topical and transdermal drug products are optimized for efficacy, safety, and commercial viability. 

Key Components of API Characterization

Physicochemical Properties – Defining API Stability and Performance

Solubility and dissolution rate profiling across different pH ranges

pKa and LogP assessment to predict drug absorption

Evaluation of hygroscopicity and moisture sensitivity

Analysis of polymorphism, crystallinity, and solid-state characteristics

[Learn More About API Solubility and Stability Testing →]

Particle Size and Morphology Analysis – Optimizing Drug Delivery

Particle size distribution to ensure uniform formulation performance

Assessing the impact of API morphology on solubility, stability, and absorption

Strategies for micronization and nanotechnology to enhance bioavailability

Compatibility testing with excipients for controlled-release formulations

[Learn More About Particle Engineering and Optimization →]

Impurity Profiling and Degradation Pathway Analysis

Identification and quantification of potential API impurities

Forced degradation studies to assess API stability risks

Testing for residual solvents and elemental impurities to ensure regulatory compliance

Examination for microbial contamination to ensure preservative efficacy and safety

[Learn More About Impurity Profiling and Risk Assessment →]

Excipient Compatibility and Pre-Formulation Studies

Interaction studies between the API and excipients to promote long-term stability

Selection of permeation enhancers and solubilizers for improved drug absorption

Evaluation of preservatives, antioxidants, and emulsifiers to maintain formulation integrity

Compatibility testing for topical, transdermal, and mucosal drug delivery systems

[Learn More About Pre-Formulation and Excipient Selection →]

Regulatory-Driven API Characterization and Compliance Support

ICH-compliant API characterization reports for IND, NDA, and ANDA filings

Development and validation of analytical methods for regulatory approval

Preparation of CMC (Chemistry, Manufacturing, and Controls) documentation

GMP-compliant analytical testing for API quality assurance

[Learn More About Our Regulatory and Compliance Expertise →]

Why Choose MedPharm for API Characterization?

Industry-leading expertise in API analysis and drug formulation

Regulatory-driven characterization for IND, NDA, and ANDA compliance

Advanced analytical techniques for optimizing bioavailability and stability

Seamless integration with formulation development and process scale-up

GMP-certified laboratories for comprehensive API quality assurance

Ensure Drug Stability and Formulation Success with MedPharm’s API Characterization Expertise

With state-of-the-art analytical techniques, regulatory-driven data generation, and scientifically guided formulation strategies, MedPharm ensures that your API is fully optimized for formulation success, clinical trials, and regulatory approval.

In Silico Prediction & In Vitro Assessment

Data-Driven Insights for Optimized Drug Development

At MedPharm, we integrate in silico prediction and in vitro assessment techniques to streamline drug development, optimize formulation strategies, and enhance regulatory success. Our computational modeling and predictive analytics offer early-stage insights into drug performance, while our in vitro assessments validate bioavailability, permeation, and stability through rigorous laboratory testing.

By leveraging advanced in silico modeling alongside real-world in vitro analysis, we help pharmaceutical companies accelerate development timelines, reduce formulation risks, and generate data that supports regulatory submissions for topical and transdermal drug products.

Why Choose MedPharm for In Silico Prediction & In Vitro Assessment?

• Industry-Leading Expertise in Computational & Experimental Drug Analysis
• Regulatory-Driven In Silico & In Vitro Data for IND, NDA, and ANDA Submissions
• Seamless Integration of Predictive Modeling with Real-World Laboratory Testing
• Comprehensive Bioavailability & Permeability Assessments for Formulation Optimization
• GMP-Compliant Laboratories Supporting Data Integrity & Quality Control

Key Components of In Silico Prediction & In Vitro Assessment

In Silico Prediction – Computational Modeling for Drug Optimization

• Molecular modeling to predict active pharmaceutical ingredient (API) solubility and stability
• Drug-lipid interaction simulations for enhanced skin penetration
• Predictive tools for excipient selection and compatibility
• Absorption, distribution, metabolism, and excretion (ADME) modeling

🔹 [Learn More About In Silico Drug Modeling →]

In Vitro Assessment – Real-World Testing for Drug Performance

• In vitro release testing (IVRT) for analyzing dissolution rate and release profiles
• In vitro permeation testing (IVPT) to evaluate drug absorption across skin and mucosal barriers
• Stability testing under International Conference on Harmonisation (ICH) guidelines to assess product shelf life
• Bioequivalence testing for regulatory approval and formulation comparison

🔹 [Learn More About In Vitro Drug Testing →]

Permeation & Absorption Modeling – Predicting Drug Delivery Performance

• In silico modeling of skin penetration and transdermal absorption
• Correlation of computational results with in vitro permeation testing (IVPT)
• Optimization of penetration enhancers for improved bioavailability
• Customization of drug delivery systems for enhanced therapeutic effect

🔹 [Learn More About Permeation & Absorption Studies →]

Regulatory-Ready Data & Formulation Optimization

• Data-driven formulation refinement for Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) filings
• Integration of predictive modeling with experimental validation
• Risk mitigation strategies based on computational and experimental findings
• Regulatory-compliant reporting and quality assurance documentation

🔹 [Learn More About Our Regulatory & Compliance Expertise →]

Target Product Profile Development

Creating a Strategic Blueprint for Formulation Success

At MedPharm, Target Product Profile (TPP) Development is a crucial step in designing your topical or transdermal drug product for regulatory success and patient benefit. Our team works closely with clients to translate clinical, commercial, and regulatory goals into clear product performance criteria, establishing the foundation for a data-driven development program.

By defining your TPP early in the process, we help align formulation design, analytical testing, and process development with your ultimate regulatory and therapeutic objectives. This alignment streamlines development, reduces risk, and accelerates timelines.

Our TPP Development Approach Includes:

Therapeutic Objective Alignment
We clarify the clinical indication, target patient population, and desired therapeutic effects.

Route of Administration & Dosage Form Strategy
We choose the optimal delivery method and formulation type to ensure efficacy, enhance compliance, and meet market needs.

Performance Targets
We establish benchmarks for bioavailability, release kinetics, permeation, and tissue targeting.

Stability, Packaging, and Shelf-Life Requirements
We incorporate storage and shelf-life considerations to support commercial viability.

Regulatory & Competitive Positioning
We benchmark against reference products and align with regulatory guidance (FDA, EMA) for submissions.

Why TPP Matters

A well-defined Target Product Profile offers several benefits:

Informed formulation and excipient selection

Streamlined preclinical and clinical study design

Enhanced communication with regulators and investors

Reduced development risks, minimizing unexpected costs

Begin with the End in Mind

MedPharm’s TPP development service empowers clients to make confident, future-focused decisions, ensuring that every step in formulation, process, and testing aligns with a clear vision for success.

Preformulation Services

Laying the Scientific Groundwork for a Successful Drug Development Journey  

At MedPharm, preformulation is more than just a technical checkpoint—it’s a crucial phase where smart science sets the foundation for formulation success. Our preformulation services help you understand the fundamental physicochemical properties of your active pharmaceutical ingredient (API). This understanding enables informed, strategic decisions that minimize risk, accelerate development timelines, and maximize your product’s clinical and commercial potential. 

Whether you are developing a novel drug or reformulating an existing one, our expert team delivers precise data and insights that directly inform excipient selection, delivery strategies, and formulation design. With a focus on topical and transdermal delivery, we tailor every study to meet the specific demands of your compound and therapeutic goals. 

What Our Preformulation Services Deliver: 

• API Characterization 

• Comprehensive profiling of your compound’s physical and chemical properties, including polymorphism, hygroscopicity, pH stability, and thermal behavior. 

• Compatibility & Stability Insights 

We evaluate interactions with excipients and identify degradation pathways through advanced forced degradation studies, guiding formulation design and shelf-life planning. 

• Solubility Enhancement & Excipient Optimization 

We develop solubilization strategies and identify compatible excipients to optimize bioavailability, stability, and patient adherence. 

• Reverse Engineering 

For generic or competitive benchmarking projects, we deconstruct reference products to reveal formulation strategy, composition, and performance attributes. 

A Data-Driven Approach to De-Risking Development 

By understanding how your API behaves before committing to full-scale formulation or clinical development, MedPharm helps you: 

• Reduce the risk of late-stage formulation failure 

• Speed up the formulation optimization cycle 

• Select excipients and delivery systems that align with your product profile 

• Design more targeted and cost-effective analytical and stability studies 

Explore Our Targeted Preformulation Capabilities: 

• [Forced Degradation Studies →] 

• [Solubility & Excipient Optimization →] 

• [Reverse Engineering →] 

Build a Strong Foundation—Start with Preformulation Excellence  

With decades of experience and specialized expertise in topical and transdermal drug delivery, MedPharm’s preformulation services provide you with the clarity and confidence to move forward with purpose. 

🔹 [Contact Us to Discuss Your API →] 

Forced Degradation Studies 

Anticipating Instability. Ensuring Robustness. Accelerating Success. 

Forced degradation studies are a cornerstone of pharmaceutical development, providing critical insight into the stability and chemical behavior of drug substances and products under stress. At MedPharm, we conduct rigorous, regulatory-compliant forced degradation studies to uncover degradation pathways, identify potential impurities, and support the development of stability-indicating analytical methods. 

These studies not only strengthen regulatory submissions but also guide intelligent formulation and packaging decisions—mitigating risks and helping you reach the clinic and market with confidence. 

 🔬 Purpose of Forced Degradation Studies 

• Determine degradation pathways and mechanisms of the API and finished product 

• Identify and characterize degradation products that may impact safety or efficacy 

• Support development of stability-indicating methods per ICH Q1A (R2) and Q2(R1) guidelines 

• Predict shelf-life and guide storage conditions 

• Inform formulation development and packaging strategies 

 ⚙️ Our Approach 

Stress Conditions Simulated: 

• Thermal degradation – Elevated temperature conditions to assess heat sensitivity 

• Photolytic degradation – Exposure to light to simulate sunlight and packaging transparency 

• Oxidative degradation – Use of hydrogen peroxide and other oxidizing agents 

• Hydrolytic degradation – Acidic and basic hydrolysis to test moisture and pH sensitivity 

• Humidity stress testing – Controlled humidity conditions to evaluate hygroscopicity 

Analytical Techniques Employed: 

• HPLC with UV/Vis or MS detection 

• UPLC and LC-MS/MS for impurity profiling 

• FTIR and DSC for structural and thermal characterization 

• Chromatographic purity and impurity trend analysis over time 

 📈 Benefits of MedPharm’s Forced Degradation Services 

• Data-driven formulation refinement and risk reduction 

• Accelerated development of stability-indicating methods 

• Stronger regulatory submissions (IND, NDA, ANDA) backed by robust data 

• Better understanding of API-excipient interactions 

• Informed packaging and labeling strategies for long-term product success 

 🔗 Related Services 

• [Stability Testing →] 

• [Analytical & Bioanalytical Method Development →] 

• [Excipient Compatibility & Selection →] 

• [API Characterization →] 

 At MedPharm, our forced degradation studies go beyond regulatory compliance—they form a proactive strategy to ensure product integrity, patient safety, and formulation excellence. 

Let’s build a stronger, more stable future for your drug product. 

Solubility & Excipient Optimization 

Enhancing Stability, Bioavailability, & Formulation Efficiency 

Solubility and excipient performance are essential for the successful development of topical and transdermal products. At MedPharm, our Solubility & Excipient Optimization services combine in-depth characterization, scientific insight, and regulatory guidance to create stable, high-performing formulations tailored to your product’s delivery method and therapeutic goals. 

Whether you face challenges with poor API solubility or need to select excipients that meet global regulations and performance expectations, our experts provide strategic, data-driven solutions to streamline development, reduce risk, and improve patient outcomes. 

We help you address critical questions from the outset: 

✔ Is your API soluble enough to provide therapeutic benefits? 

✔ Are your excipients compatible, scalable, and acceptable to regulators? 

✔ Can your formulation maintain stability and efficacy throughout its shelf life?  

This service includes two focused sub-areas to support your development journey:  

🔍 Excipient Compatibility and Selection 

Strategically match your API with excipients to ensure stability, performance, and compliance. Our formulation scientists evaluate potential interactions, optimize the roles of functional excipients (e.g., permeation enhancers, emulsifiers, preservatives), and align your formulation with the demands of its delivery method and target market. 

💧 Solubility & Bioavailability Enhancement Studies 

Enhance the solubility and absorption of poorly water-soluble APIs using innovative approaches such as co-solvents, surfactants, lipid-based systems, and nanoemulsions. Our team conducts solubility screening, bioavailability modeling, and early-phase testing to identify the most promising formulation strategies. 

 Excipient Compatibility & Selection

Optimizing Stability, Efficacy, and Formulation Integrity

At MedPharm, the selection of excipients is not just a matter of compiling a list of ingredients; it is a scientifically grounded formulation strategy built on regulatory insights, mechanistic understanding, and performance optimization. The excipients you select will directly influence drug stability, permeability, patient acceptability, and regulatory success. Our approach ensures that every decision is intentional and informed by risk assessment.

Whether you are developing a new chemical entity or reformulating an existing product, we assist you in choosing excipients that enhance product quality, consistency, and clinical success from the earliest development stages.

What We Do

Excipient-API Compatibility Studies

We utilize a comprehensive suite of analytical techniques to assess potential interactions between active pharmaceutical ingredients (APIs) and excipients. This includes:

– Forced degradation studies to simulate worst-case scenarios

– Differential Scanning Calorimetry (DSC) and Thermal Gravimetric Analysis (TGA)

– FTIR spectroscopy and HPLC-based impurity profiling

– Moisture sorption analysis to evaluate hygroscopicity

By understanding stability vulnerabilities upfront, we help de-risk the formulation development process and prevent costly reformulations or regulatory setbacks later on.

Targeted Excipient Selection

Leveraging an extensive library of Generally Recognized As Safe (GRAS), USP/NF, Ph. Eur., and JP-approved excipients, our formulation scientists strategically select components that are:

– Compatible with the physical and chemical properties of your API

– Appropriate for your route of delivery and target patient population

– In accordance with market-specific regulatory guidelines

– Supported by proven performance in similar formulations

Each recommendation is aligned with your Target Product Profile (TPP), ensuring that the final formulation is both functional and future-focused.

Functional Role Assessment

We evaluate each excipient not only for compatibility but also for its critical role in enhancing product performance, including:

– Permeation Enhancers: Facilitate faster or deeper drug delivery through skin, mucosa, or nails

– Solubilizers, Emulsifiers, and Surfactants: Improve drug solubility and ensure consistent product texture and performance

– Preservatives and Antioxidants: Guard against microbial growth and oxidative degradation

– Gelling Agents and Viscosity Modifiers: Ensure user-friendly application and physical stability in topical formats

– pH Buffers and Chelating Agents: Optimize the formulation environment and prevent metal-catalyzed degradation

Global Regulatory Considerations

Our excipient strategy includes a market-readiness evaluation against major regulatory bodies:

– FDA (U.S.), EMA (Europe), PMDA (Japan), ANVISA (Brazil)

– Pre-cleared excipient use to prevent regulatory rejections

– Documentation-ready rationales for regulatory submissions

– Insight into regional excipient restrictions and historical precedents

We anticipate and address potential market-specific formulation challenges before they become major obstacles.

Benefits of MedPharm’s Excipient Strategy

– Reduced risk of formulation failure, instability, or regulatory delays

– Increased alignment with clinical, commercial, and patient-use objectives

– Accelerated development through data-driven selection and minimized trial-and-error

– Enhanced support for regulatory submissions (IND, NDA, ANDA, IMPD)

Related Services

– API Characterization

– Solubility & Bioavailability Enhancement

– Stability Testing

– Target Product Profile Development

Solubility & Bioavailability Enhancement Studies 

Unlocking Therapeutic Potential Through Smart Formulation Strategies 

Solubility and bioavailability are among the most critical challenges in drug development—particularly for topical and transdermal formulations where localized delivery and systemic absorption must be carefully balanced. At MedPharm, we design and execute scientifically robust studies to improve the solubility of poorly water-soluble APIs and enhance bioavailability through customized formulation strategies. 

By applying a combination of empirical screening, predictive modeling, and formulation science, we help clients overcome solubility barriers that limit therapeutic effect, patient outcomes, and regulatory success. 

 🔬 What We Do 

Solubility Profiling Across Multiple pH Ranges 

We systematically assess API solubility in aqueous and non-aqueous media across relevant pH conditions to identify solubility-limiting factors and inform formulation direction. 

Excipients & Solubilizer Screening 

Our team screens a wide range of pharmacopeia-approved solubilizers, surfactants, co-solvents, and lipid systems to identify the best-fit excipients for improving solubility and maintaining physical and chemical stability. 

Advanced Solubilization Techniques 

We employ innovative formulation technologies tailored to each compound’s profile: 

Nanoemulsions for improved skin and mucosal penetration 

Solid and Liquid Lipid Carriers for enhanced permeability and sustained release 

Cyclodextrin Complexation to improve aqueous solubility and reduce irritation 

Co-solvent Systems that balance performance and patient tolerability 

Preliminary Formulation Screening for Bioavailability 

Our in vitro testing platforms—paired with permeation studies—evaluate the impact of solubility enhancements on drug delivery efficiency, absorption, and overall bioavailability. 

 📈 Benefits of Our Approach 

Enables clinical success by improving drug release, permeability, and absorption 

Reduces risk of late-stage formulation failure and costly reformulation 

Generates compelling data for IND, ANDA, and NDA submissions 

Accelerates timelines for poorly soluble APIs using evidence-backed pathways 

Integrates seamlessly with our formulation and process development workflows 

 🔗 Related Services 

[Excipient Compatibility & Selection →] 

[API Characterization →] 

[In Vitro Permeation Testing (IVPT) →] 

MedPharm’s solubility and bioavailability enhancement studies help ensure your topical and transdermal products are primed for success—scientifically, clinically, and commercially. 

Let us help you unlock the full potential of your compound. 

Reverse Engineering 

Optimizing and Reconstructing Drug Formulations for Bioequivalence and Market Competitiveness

At MedPharm, our Reverse Engineering services empower pharmaceutical companies to analyze, deconstruct, and replicate existing drug formulations to meet bioequivalence, regulatory, and market demands. Whether developing generic equivalents, improving current formulations, or tackling stability and performance challenges, our expert team employs advanced analytical techniques to identify active pharmaceutical ingredient (API) compositions, excipient profiles, and critical formulation characteristics.

MedPharm ensures that your re-engineered product meets the highest industry standards for safety, efficacy, and market competitiveness by utilizing state-of-the-art analytical instrumentation, regulatory-driven methodologies, and expertise in topical and transdermal drug formulations.

Key Components of Reverse Engineering

Comprehensive Drug Product Analysis

• Identification of active pharmaceutical ingredients (APIs) and excipients
• Quantification of drug concentrations and formulation components
• Evaluation of pH, viscosity, rheology, and overall formulation properties
• Assessment of delivery systems for drug absorption and stability

🔹 [Learn More About API Characterization →]

Excipient Profiling and Compatibility Assessment

• Determination of excipient roles (e.g., stabilizers, penetration enhancers, surfactants)
• Compatibility testing for API-excipient interactions
• Evaluation of preservative and antioxidant effectiveness
• Selection of suitable excipients for improving drug performance and stability

🔹 [Learn More About Excipient Compatibility →]

Analytical and Performance Testing for Bioequivalence

• In vitro release testing (IVRT) to assess dissolution rates and drug diffusion
• In vitro permeation testing (IVPT) to compare absorption profiles through skin or mucosal membranes
• Stability testing to align shelf life and degradation characteristics with the reference product
• Comparative analytical method validation for regulatory compliance

🔹 [Learn More About Bioequivalence Testing →]

Reformulation and Process Optimization

• Reconstruction of target formulations using matched or improved excipients
• Process development to ensure reproducibility and scalability
• Optimization of mixing, emulsification, and homogenization parameters
• Technology transfer planning for clinical and commercial-scale production

🔹 [Learn More About Process Development and Scale-Up →]

Regulatory and Market-Readiness Support

• Regulatory-compliant formulation reports for ANDA, NDA, and 505(b)(2) submissions
• Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory approval
• Risk mitigation strategies for formulation variations
• Good Manufacturing Practice (GMP)-compliant manufacturing support for seamless commercialization

🔹 [Learn More About Our Regulatory and Compliance Expertise →]

Why Choose MedPharm for Reverse Engineering?

• Industry-leading expertise in formulation analysis and reconstruction
• Regulatory-driven reverse engineering for bioequivalent drug development
• Advanced analytical and stability testing for NDA and ANDA submissions
• Seamless integration with process development and scale-up strategies
• GMP-certified facilities supporting clinical and commercial manufacturing

Reformulate, Optimize, and Compete with MedPharm’s Reverse Engineering Expertise

With scientifically driven formulation deconstruction, analytical expertise, and bioequivalence validation, MedPharm ensures that your re-engineered drug product is optimized for regulatory approval, patient compliance, and market success.

Selection & Optimization 

Transforming Formulation Concepts into Clinical-Ready Products

At MedPharm, the Selection & Optimization phase represents a crucial turning point where early-stage insights evolve into refined, high-performing formulations designed for success. By leveraging comprehensive data from pre-formulation studies, physicochemical analysis, and in vitro testing, our scientists transform promising concepts into viable drug product candidates—ready for clinical development and regulatory advancement.

This stage is where scientific expertise meets precise engineering. Our formulation experts combine decades of experience with automated high-throughput platforms and a rigorous Quality by Design (QbD) framework to fine-tune dosage forms for real-world performance. We optimize for drug efficacy, stability, manufacturability, and patient usability, ensuring that each formulation not only meets your Target Product Profile (TPP) but also aligns with global regulatory standards and commercial viability.

Whether you are advancing a new chemical entity or reverse-engineering a generic product, our iterative and data-driven development model accelerates your timeline, reduces formulation risk, and prepares your drug product for clinical trials with confidence.

Our Selection & Optimization Services Include:

Formulation Prototype Preparation
We create multiple formulation prototypes across various dosage forms (e.g., creams, gels, sprays, patches) based on active pharmaceutical ingredient (API) characterization and delivery objectives. These prototypes are rigorously screened for performance and manufacturability.

Lead Formulation Selection
Using predefined success criteria, our team assists in selecting a lead formulation and backup option based on in vitro performance, stability, scalability, and regulatory alignment. Client collaboration is central to this process, ensuring your product goals remain prioritized.

Preliminary Process Assessment
For both novel and generic formulations, we assess manufacturing feasibility early. We analyze processing parameters such as mixing, temperature control, and order of addition to identify optimal approaches and reduce scale-up variability.

Reverse Engineering (for Generics)
When developing generic equivalents, we reverse-engineer reference listed drugs (RLDs) to match their composition and microstructure. Our state-of-the-art analytical techniques ensure bioequivalent performance while enabling efficient replication.

Optimization Tools & Techniques

• Design of Experiments (DoE) for robust process understanding
• Automated High-Throughput Screening for efficiency and repeatability
• Integration of In Vitro Testing for release, permeation, and biological activity
• Short-Term Stability Studies to identify formulation risks early

The MedPharm Advantage

• Streamlined transition from pre-formulation to clinical formulation
• Proactive risk mitigation through real-time testing and iterative development
• Global regulatory foresight integrated into every formulation decision
• A collaborative approach that keeps your goals at the forefront

Related Pages

• Early-Stage Evaluation & Strategic Planning
• Process Development
• In Vitro Testing

Prototype Preparation 

Translating Formulation Concepts into Reality  

At MedPharm, Prototype Preparation acts as the bridge between theoretical formulation design and hands-on performance testing. This early-stage service enables our clients to evaluate the real-world feasibility, aesthetic qualities, and functional behavior of their products before committing to full development and scale-up.  

Whether you are developing a novel topical therapy or reformulating an existing product, our expert formulators create small-scale prototypes using targeted excipients, dosage forms, and delivery platforms. Each prototype is designed to assess how your drug candidate performs in various formulation environments.  

Key Benefits  

• Accelerated Feasibility Assessment: Identify promising formulation directions early, saving time and development costs.  

• Topical & Transdermal Specialization: Focused expertise in semisolids, liquids, gels, foams, lotions, and sprays.  

• Patient-Centric Design: Evaluate spreadability, absorption, feel, and visual appeal alongside functional performance.  

• Flexible & Iterative Process: Rapid turnaround for multiple variations to support parallel testing and optimization. 

Your First Step Toward a Viable Drug Product  

Our formulation scientists collaborate closely with your R&D and regulatory teams to align prototypes with your target product profile (TPP), clinical pathway, and market goals. We will help you define the most suitable route forward based on scientific principles, stability, manufacturability, and patient experience.  

Let’s create something real—together. 

 Short-Term Stability Screening 

Rapid Risk Assessment for Formulation Viability 

After developing a prototype, MedPharm’s Short-Term Stability Screening offers a quick and focused evaluation of formulation integrity under stress conditions. This essential service helps sponsors swiftly eliminate unstable candidates, refine excipient choices, and identify the most robust pathways for further development. 

By simulating potential degradation risks early in the process, we assist our partners in saving valuable time, reducing rework, and confidently progressing toward long-term stability and scale-up. 

What We Assess 

• Physical and Chemical Stability 

• Monitor changes in pH, appearance, viscosity, and assay under controlled temperature and humidity. 

• Preservative Effectiveness & Microbiological Screening 

Screen for the risk of microbial growth in aqueous formulations. 

• Photostability and Oxidation Sensitivity 

Evaluate the exposure of APIs or formulations to light, air, or heat. 

• Rheological Behavior Over Time 

Determine consistency and usability during the early storage phases. 

• Early Packaging Compatibility 

Identify interactions with initial container-closure systems. 

Fast Insights, Strong Foundations 

Short-term stability screening at MedPharm typically takes a few days to a few weeks, offering rapid feedback before investing in formal ICH studies. Results guide: 

• Excipient selection  

• Packaging decisions  

• Development timelines  

• Regulatory risk mitigation 

Build Confidence Before You Scale 

At MedPharm, short-term screening is more than just a procedural step; it’s a proactive strategy to mitigate risks in your development process. When combined with prototype preparation, it empowers your team to make informed, data-driven decisions early in the product journey. 

Let’s screen smarter and move forward faster. 

Lead Formulation Selection

Identifying the Optimal Drug Formulation for Clinical and Commercial Success 

MedPharm’s Lead Formulation Selection services ensure that topical and transdermal drug products are optimized for efficacy, stability, bioavailability, and patient adherence before advancing to clinical trials. We help pharmaceutical companies identify the most promising formulations that meet regulatory requirements and commercial viability through data-driven formulation screening, rigorous analytical testing, and regulatory-aligned selection criteria. 

With our expertise in creams, gels, lotions, foams, transdermal patches, and other advanced delivery systems, MedPharm guarantees that your lead formulation is optimized for scale-up, manufacturing, and regulatory approval. 

Key Components of Lead Formulation Selection 

Comprehensive Formulation Screening and Optimization 

• Evaluation of multiple formulation prototypes for efficacy and stability. 

• Optimization of excipients, drug solubilization, and permeation enhancers. 

• Selection of the most effective delivery system to enhance patient compliance. 

• Customization for immediate, extended, or controlled drug release. 

🔹 [Learn More About Formulation Development →] 

Analytical Testing and Bioavailability Enhancement 

• In vitro release testing (IVRT) analyzes dissolution and drug release rates. 

• In vitro permeation testing (IVPT) to assess drug absorption across skin and mucosal tissues. 

• Stability testing under ICH guidelines to evaluate formulation shelf life. 

• Assessment of penetration enhancers to optimize bioavailability. 

🔹 [Learn More About Analytical and Stability Testing →] 

Process Development and Scalability Readiness 

• Evaluation of formulations for manufacturability and feasibility of large-scale production. 

• Batch-to-batch consistency studies to ensure reproducibility in commercial settings. 

• Technology transfer planning for clinical and commercial manufacturing. 

• Optimization of mixing, emulsification, and homogenization processes. 

🔹 [Learn More About Process Development and Scale-Up →] 

Regulatory-Driven Selection Criteria 

• Alignment with FDA, EMA, and ICH guidelines for regulatory approval. 

• Bioequivalence and bioavailability data to support IND, NDA, and ANDA filings. 

• Preparation of CMC (Chemistry, Manufacturing, and Controls) documentation. 

• Risk mitigation strategies for formulation modifications and lifecycle management. 

🔹 [Learn More About Regulatory and Compliance Expertise →] 

Why Choose MedPharm for Lead Formulation Selection? 

• Industry-leading expertise in topical and transdermal formulation development. 

• Regulatory-driven approach for compliance with IND, NDA, and ANDA. 

• Advanced analytical and bioavailability testing for optimized formulation performance. 

• Seamless integration with scale-up and technology transfer for manufacturing. 

• GMP-certified facilities supporting both clinical and commercial production. 

Ensure Drug Formulation Success with MedPharm’s Lead Formulation Selection Expertise 

With scientifically driven formulation optimization, advanced analytical testing, and regulatory-aligned selection criteria, MedPharm ensures that your topical and transdermal drug formulations are fully optimized for clinical success and commercial viability. 

Optimization & Refinement 

Fine-Tuning Formulations for Performance, Stability, and Scale  

Once a promising prototype has been identified and its preliminary stability evaluated, it’s time to elevate it to its final form. At MedPharm, our Optimization & Refinement services are where your drug product transitions from concept to a formulation prepared for clinical testing and eventual commercialization. 

This stage transforms good formulations into great ones, ensuring they meet regulatory expectations, manufacturing requirements, and patient-centric goals—all without compromising quality or performance. 

What We Optimize 

Our formulation scientists collaborate with analytical, manufacturing, and regulatory teams to systematically refine the following: 

• Excipient Compatibility & Ratios: Improve API solubility, uniformity, and delivery while maintaining patient safety and regulatory compliance.  

• Viscosity & Rheology: Ensure optimal spreadability, application consistency, and drug delivery kinetics.  

• Preservative Systems: Select or adjust antimicrobial agents for effectiveness and global regulatory acceptance.  

• Stability Profile: Refine formulations to enhance resistance to degradation over time, as well as to temperature and light exposure.  

• Sensory & Aesthetic Properties: Adjust texture, color, odor, and feel to support user adherence and commercial appeal.  

• Process Compatibility: Modify the formulation to fit scalable and reproducible manufacturing processes. 

Data-Driven Formulation Excellence 

Optimization is not a process of trial and error; it is a targeted, data-informed iteration. At MedPharm, we utilize insights from: 

• Short-term and long-term stability data  

• In vitro release and permeation testing (IVRT/IVPT)  

• Rheological profiling  

• Microbiological screening  

• Analytical method feedback  

• Client target product profile (TPP) requirements 

The outcome? A robust formulation that performs consistently under real-world conditions and meets regulatory standards. 

Why MedPharm?  

• Topical and Transdermal Expertise: We understand the unique behaviors of semisolids, liquids, and skin-targeted delivery.  

• Collaborative Refinement: We work alongside your team to align scientific data with strategic goals.  

• Regulatory Alignment: Our refinements are grounded in global regulatory requirements and submission strategies.  

• Manufacturing-Ready Thinking: Every adjustment is made with scale-up and technology transfer in mind. 

From Viable to Virtually Unshakeable 

Your formulation may be functional; however, with MedPharm’s optimization and refinement, it can become exceptional. We don’t just adjust—we elevate. 

Let’s refine your formulation for long-term success.