Stainless-steel formulation bench with dosing vials, an analytical balance, and a stirred suspension in a preclinical laboratory

Preclinical Formulation Development

A formulation your study can actually dose.

Lovelace Biomedical develops simple to complex formulations for parenteral, oral, dermal, and inhaled dosing — then verifies every dose formulation in our own analytical laboratories before the first animal is dosed.

Discuss Your Molecule Explore Capabilities
4 routesParenteral, oral, dermal, and inhaled
Same campusFormulation, toxicology & bioanalysis together
5 attributesContent, stability, purity, pH, homogeneity
1984Continuous GLP compliance since
On-site analytical chemistry GLP & non-GLP dose formulation analysis Small molecules through biologics Formulation, dosing & bioanalysis on one campus Albuquerque, NM · Est. 1947

Formulation is one service within Preclinical Development Services — alongside inhalation toxicology, general toxicology, pharmacology, DMPK & bioanalysis, and pathology.

Back to Preclinical Development Services

The Lovelace Advantage

Formulation is where preclinical programs quietly fail.

A poorly characterized vehicle produces unusable exposure, unexplained toxicity, or a study that has to be repeated. Our analytical chemists build the formulation around the route, target site, and pharmacokinetics of your molecule — and because the same campus runs the toxicology, DMPK, and bioanalytical work, dosing problems get diagnosed by the people who generated the data.

  • Route selected against target site and disposition
  • Solubility, excipient, and vehicle screening
  • Respiratory formulation for nebulizers, MDIs, and DPIs
  • CNS-compatible intrathecal vehicle development
  • Dose formulation analysis under GLP
  • Stability coverage across the dosing window
  • Direct handoff to the study team that doses it
  • Species- and volume-appropriate dose concentrations
Bank of chromatography instruments with autosampler trays used for dose formulation analysis Analytical chemistry laboratories

Formulation Services

From vehicle screen to GLP dose release.

Use a single capability to unblock a study, or hand us the molecule and the intended clinical route and let our chemists build and qualify the dosing solution end to end.

01

Formulation Development

Simple through complex formulations — solutions, suspensions, emulsions, and semi-solids — designed around target site, bioavailability, disposition, and the pharmacokinetics of the therapeutic entity.

02

Respiratory Formulation

Nebulizer solutions and suspensions, metered-dose inhaler formulations, and dry powders, developed alongside the aerosol scientists who will generate and characterize the exposure atmosphere.

03

Parenteral & Oral Formulation

Injectable vehicles for IV, IM, SC, IP, and intrathecal administration, plus oral solutions, suspensions, and gavage vehicles matched to species, dose volume, and tolerability limits.

04

Dermal & Topical Formulation

Creams, gels, ointments, and solution vehicles for local-delivery and local-tolerance programs, with attention to vehicle irritation potential and site-of-application endpoints.

05

Dose Formulation Analysis

Content, stability, purity, pH, and homogeneity testing on the actual dosing preparations, so delivered dose is documented rather than assumed.

06

Integrated Study Support

Formulation preparation and release aligned to the dosing calendar of the toxicology, pharmacology, or DMPK study running on the same campus.

How We Work

Four steps from difficult molecule to releasable dose.

We start with the molecule, the intended clinical route, and the study you need to run — then work backward to a formulation that survives preparation, handling, and the full dosing window.

01

Define the dosing target

Route, species, dose levels, volumes, and frequency set the physical limits the formulation has to meet.

02

Screen and select

Solubility, vehicle, and excipient screening identifies the simplest preparation that achieves the target concentration.

03

Qualify analytically

Analytical methods established to confirm the preparation is dosable across the intended use period.

04

Release to study

Prepared, analyzed, and documented dose formulations delivered on schedule to the in-life team.

Routes & Modalities

The route drives the formulation, not the reverse.

The desired route of administration is chosen against target site, bioavailability and disposition, and the pharmacokinetics of the therapeutic entity — then the formulation is built to serve it.

Inhaled

Nebulizer, metered-dose inhaler, and dry powder formulations developed with aerosol performance and delivered dose in view from the start.

Parenteral

IV, IM, SC, IP, and intrathecal vehicles balancing solubility, tonicity, pH, and injection-site tolerability at the required concentration.

Oral

Solutions, suspensions, and gavage vehicles with homogeneity and resuspension behavior verified for the dosing window.

Dermal & Topical

Semi-solid and solution preparations for local delivery, local tolerance, and site-of-application safety programs.

Small Molecules

Poorly soluble candidates, salt and cosolvent strategies, and high-concentration preparations for toxicology dose ranges.

Biologics & Complex Modalities

Peptides, proteins, antibodies, nucleic-acid therapies, and particle-based systems, handled with modality-appropriate stability controls.

Dose Formulation Analysis

Every dose accounted for, on the record.

Reviewers do not accept a nominal dose. Our analytical chemists characterize the preparation your animals actually received, giving your toxicology and toxicokinetic conclusions a defensible foundation.

"Dose formulations can be analyzed for content, stability, purity, pH and homogeneity."
Lovelace Biomedical, Formulation Services
  • Content / strengthConcentration verified against target
  • HomogeneityTop, middle, and bottom sampling
  • StabilityAcross the intended use period
  • Correction FactorsPotency, salt-form, and moisture adjustments
  • pHConfirmed for route tolerability
  • DocumentationGLP-compliant records and reporting
Dry powder inhaler, metered-dose inhaler canister, nebulizer cup, and micronized powder beside a cascade impactor Respiratory formulation development

Frequently Asked

Questions sponsors ask before sending compound.

This is one of the most common reasons programs come to us. We screen vehicles, cosolvents, surfactants, and suspension approaches to reach the concentration your high-dose group requires while staying inside species-appropriate tolerability limits, and we tell you early if the target dose is not physically achievable rather than after a failed study.
Yes. Formulation preparation and dose formulation analysis are performed to support both non-GLP investigational work and GLP regulatory toxicology studies, with documentation and reporting built for inclusion in IND, NDA, and BLA submissions.
Yes — we take standalone formulation development and dose formulation analysis work, including support for studies running elsewhere. Most sponsors bundle it with the study because a single team then owns the link between prepared dose, delivered dose, and observed effect.
Structure or modality, available physicochemical and solubility data, any existing formulation and analytical method, the intended clinical route, and the target dose levels and species. That is usually enough for our chemists to propose an approach and a realistic timeline.
Our teams support peptides, proteins, antibodies, nucleic-acid therapies, and particle-based delivery systems alongside traditional small molecules, with handling, stability, and analytical controls appropriate to each modality.

Send us the molecule and the route.

Our analytical chemists will tell you what is formulable, what it will take, and how it fits the study you are planning.

Contact Our Team (505) 348-9400