LumiMicro Life Sciences

Primary service 03

Topical Formulation & Prototype Studies

A staged route from product goal to research-scale prototype and early performance. Enter at whichever stage your project is at—no project is required to complete every module. Goal definition, feasibility and interpretation are provided directly; laboratory work is available by project.

Discuss a topical formulation project
  1. AProduct Goal
  2. BMaterials
  3. CVehicle & Formulation
  4. DPrototype
  5. ECharacterisation
  6. FDelivery & Reporting

Product goal → materials → vehicle and formulation → prototype → characterisation → optional delivery, analysis and reporting. Enter at any stage; modules can be selected singly or combined.

A

Product Goal & Feasibility

For projects where the research route or formulation direction is not yet settled.

Where this helps

  • You have a product idea but no defined development route.
  • You are unsure whether the target is local action or transdermal delivery.
  • You need to know which risks to resolve first, and in what order.

What we provide

Provided directly

  • Definition of product type, application site and local or transdermal target
  • Review of active and dose range at a non-confidential level
  • Dosage-form preference, application mode and sensory goal discussion
  • Assessment of existing materials, formulations, samples, methods or references
  • Identification of principal technical, stability, analytical and external-execution risks

What you take away

  • A clear statement of the development question and what the next round must decide
  • Which modules your project actually needs, and in what order
  • Which risks will govern feasibility
  • Whether the intended route is realistic at the current stage

Possible outputs

Development question and objective summary · Feasibility note · Module selection and research roadmap · Sample, method and responsibility list

What to send first

Non-confidential product concept and intended application site · Active class and approximate dose range · Existing materials, formulations, data or references · The decision this round must support

Scope. Advisory and planning work. A feasibility note does not constitute a commitment to execute any subsequent module, nor any assurance of technical, regulatory or commercial outcome.

B

Material & Excipient Screening

For projects with a defined active but no settled base or key excipients.

Where this helps

  • You have an active but have not settled on a base or key excipients.
  • You need to know which excipient candidates are compatible before formulating.
  • You are seeing separation, precipitation or appearance changes and need the cause narrowed.

What we provide

Provided directly

  • Screening study design and candidate range definition
  • Interpretation of observations and exclusion rationale

Available by project

  • Active solubility, dispersion and compatibility screening
  • Oil phase, aqueous phase, solvent, surfactant and thickener candidate screening
  • Appearance, sedimentation, precipitation, phase separation and short-term change observation
  • pH, viscosity and early rheological suitability
  • Basic container, filtration, sampling and downstream analytical compatibility

What you take away

  • Which excipient candidates remain viable, and which are excluded and why
  • Whether the active is compatible with the intended base
  • The minimum candidate range worth carrying forward

Possible outputs

Material and excipient screening matrix · Observation records and candidate range · Principal risks, limitations and recommended formulation direction

What to send first

Active class and approximate dose range at a non-confidential level · Intended dosage form · Excipients already tried and what was observed · Samples, where required, through an agreed route

Scope. Research-scale screening. Results describe observed behaviour under the stated conditions and do not establish stability, compatibility or performance in a finished product. Complete formulations, customer-proprietary parameters and unpublished results are not disclosed on this website.

C

Vehicle & Formulation Screening

For projects comparing vehicles, bases or early formulation directions.

Where this helps

  • You need to compare solution, suspension, emulsion, gel or cream routes.
  • You want to explore key excipient levels before committing to a lead.
  • You need candidate formulations narrowed to a manageable set.

What we provide

Provided directly

  • Screening design, comparison logic and convergence criteria
  • Interpretation of screening results and direction recommendation

Available by project

  • Research-grade solution, suspension, emulsion, gel, cream and other vehicle comparison
  • Exploratory comparison of key excipients and level ranges
  • Preparation sequence, shear, mixing, temperature, addition and de-aeration factors
  • Appearance, homogeneity, pH, viscosity and other agreed preliminary attributes
  • Short-term physical change and basic handling observation

What you take away

  • Which vehicle route suits the active and the application
  • Which candidate formulations to carry forward, and which to drop and why
  • Which preparation factors materially affect the outcome

Possible outputs

Formulation screening matrix · Experimental records and observation summary · Candidate formulation directions · Directions not recommended, with reasons · Recommended next prototype or performance work

What to send first

Target dosage form and application mode · Outcome of any earlier material screening · Constraints on excipients, pH or viscosity · The comparison the round needs to settle

Scope. Research-scale screening. Candidate formulations are exploratory and do not represent an optimised, stable or manufacturable product. Complete formulations and customer-proprietary parameters are not published.

D

Prototype & Process Feasibility

For projects with a candidate formulation that need research-scale prototypes and an initial view of process risk.

Where this helps

  • You have a candidate formulation and need research-scale prototypes prepared.
  • You need to understand which process steps carry the most risk.
  • You need numbered, allocated samples for downstream work.

What we provide

Provided directly

  • Process route definition and critical step identification
  • Interpretation of deviations and recommended optimisation

Available by project

  • Small-scale preparation steps and critical operation sequence
  • Mixing, emulsification, dispersion, homogenisation, heating, cooling, de-aeration and filling
  • Research-scale batches, numbering and sample allocation
  • Appearance, homogeneity, spreadability, samplability and packaging suitability
  • Small-range process variable and repeatability observation

What you take away

  • Whether the formulation can be prepared reproducibly at research scale
  • Which process variables carry the greatest risk
  • The minimum experiments needed for the next optimisation round

Possible outputs

Research-scale prototypes or agreed samples · Process flow diagram and experimental records · Preliminary process window · Risks, deviations and recommended next optimisation

What to send first

Candidate formulation at a non-confidential level · Target batch size and sample quantity · Equipment available to you · Downstream use of the prototypes

Scope. Research-scale prototypes are not sterile, GMP, clinical, registration, commercial-scale or saleable product. No process validation, batch release or manufacturing readiness is implied.

E

Characterisation & Performance

For projects comparing prototype quality attributes or early performance.

Where this helps

  • You need prototype quality attributes measured and compared.
  • You want early performance signals before committing to a larger programme.
  • You need preliminary stability observations under agreed conditions.

What we provide

Provided directly

  • Characterisation plan and endpoint selection
  • Interpretation of results, including stated limitations

Available by project

  • Appearance, homogeneity, pH, viscosity, rheology and mechanical properties
  • Content and related analytical support, per project
  • Preliminary stability observation under short-term, accelerated or agreed conditions
  • Release, diffusion, adhesion, film formation and other dosage-form-relevant exploratory performance

What you take away

  • How the prototypes compare on the attributes that matter
  • Whether early performance supports the intended product concept
  • Which attributes still need data before a conclusion can be drawn

Possible outputs

Characterisation data tables and figures · Observation records · Preliminary stability summary · Technical report stating method, model and limitations

What to send first

Prototypes or samples with storage conditions as agreed · Attributes to be compared · Any specification or reference targets · Existing data, if any

Scope. Results hold only within the stated specification, method and model. Preliminary stability observation is not a stability study to a recognised guideline and does not establish shelf life. No human performance, safety, clinical benefit or regulatory acceptance is established by this work.

F

Optional Delivery, Analytical & Reporting Support

Optional. Skin delivery evaluation, analytical support and technical reporting, connected to this project or reviewed from work performed elsewhere.

Where this helps

  • You need release or skin delivery evidence for a topical prototype.
  • You have data and want it structured into a technical report.
  • You have a report from another party and want it reviewed.

What we provide

Provided directly

  • Study design and endpoint selection for release or skin delivery work
  • Review of data, protocols or reports produced by you or another party
  • Structuring of calculations, figures, limitations and next steps

Available by project

  • Release or skin delivery evaluation, coordinated through the IVRT & IVPT service
  • Sample extraction and quantification, confirmed separately

What you take away

  • Whether the delivery evidence supports the product concept
  • Whether an existing report's conclusions can be relied on
  • What evidence to add before the next decision

Possible outputs

Agreed study plan, results or data tables · Quality control and deviation summary · Structured technical report or report review note · Recommended next step

What to send first

Prototypes or samples · The delivery question to be answered · Existing data or reports · Who will perform any analysis

Release and skin delivery work is run under our IVRT & IVPT Support service. Microneedle-specific delivery questions are covered under Microneedle Development & Research Tools.

Scope. Analytical site, methods, suitability, validation status, quality system, raw data and report responsibility are confirmed per project. Does not constitute GLP/GMP, clinical, registration or regulatory acceptance, and implies no certainty of outcome.

Start with a non-confidential question.

Describe the product you are working towards, what stage the work has reached, and the decision the next round needs to support. We help define the smallest sufficient set of modules.

Discuss a topical formulation project